Radiation Protection, 43284-43300 [2014-17252]
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules
(i) Six-rowed Malting barley. Barley
that has a minimum of 95.0 percent of
a six-rowed suitable malting type that
contains not more than 1.9 percent
injured-by-frost kernels, 0.4 percent
frost-damaged kernels, 0.2 percent
injured-by-heat kernels, and 0.1 percent
heat-damaged kernels, 1.9 percent
injured-by-mold kernels, and 0.4
percent mold-damaged kernels. Sixrowed Malting barley shall not be
infested, blighted, ergoty, garlicky, or
smutty as defined in § 810.107(b) and
§ 810.206.
(ii) Two-rowed Malting barley. Barley
that has a minimum of 95.0 percent of
a two-rowed suitable malting type that
contains not more than 1.9 percent
injured-by-frost kernels, 0.4 percent
frost-damaged kernels, 0.2 percent
injured-by-heat kernels, 0.1 percent
heat-damaged kernels, 1.9 percent
injured-by-mold kernels, and 0.4
percent mold-damaged kernels. Two-
Minimum limits of—
Grade
U.S.
U.S.
U.S.
U.S.
No.
No.
No.
No.
Test weight
per bushel
(pounds)
1
2
3
4
§ 810.204
[Amended]
3. Section 810.204 is revised to read
as follows:
■
§ 810.204 Grades and grade requirements
for Six-rowed Malting barley.
Maximum limits of—
Suitable
malting
types
(percent)
47.0
45.0
43.0
43.0
rowed Malting barley shall not be
infested, blighted, ergoty, garlicky, or
smutty as defined in § 810.107(b) and
§ 810.206.
*
*
*
*
*
Sound
barley 1
(percent)
97.0
97.0
95.0
95.0
Damaged
kernels 1
(percent)
98.0
98.0
96.0
93.0
Wild oats
(percent)
2.0
3.0
4.0
5.0
Foreign
material
(percent)
1.0
1.0
2.0
3.0
Other grains
(percent)
Skinned and
broken
kernels
(percent)
Thin barley
(percent)
2.0
3.0
5.0
5.0
4.0
6.0
8.0
10.0
7.0
10.0
15.0
15.0
0.5
1.0
2.0
3.0
1 Injured-by-frost kernels and injured-by-mold kernels are not considered damaged kernels or considered against sound barley.
Note: Malting barley shall not be infested in accordance with § 810.107(b) and shall not contain any special grades as defined in § 810.206.
Six-rowed Malting barley varieties not meeting the requirements of this section shall be graded in accordance with standards established for the
class Barley.
§ 810.205
[Amended]
§ 810.205 Grades and grade requirements
for Two-rowed Malting barley.
4. Section 810.205 is revised to read
as follows:
■
Minimum limits of—
Grade
U.S.
U.S.
U.S.
U.S.
No.
No.
No.
No.
Test weight
per bushel
(pounds)
1
2
3
4
50.0
48.0
48.0
48.0
Maximum limits of—
Suitable
malting
types
(percent)
Sound
barley 1
(percent)
97.0
97.0
95.0
95.0
Damaged
kernels 1
(percent)
98.0
98.0
96.0
93.0
Wild Oats
(percent)
2.0
3.0
4.0
5.0
Foreign
material
(percent)
1.0
1.0
2.0
3.0
Other grains
(percent)
Skinned and
broken
kernels
(percent)
Thin barley
(percent)
2.0
3.0
5.0
5.0
4.0
6.0
8.0
10.0
5.0
7.0
10.0
10.0
0.5
1.0
2.0
3.0
1 Injured-by-frost kernels and injured-by-mold kernels are not considered damaged kernels or considered against sound barley.
Note: Malting barley shall not be infested in accordance with § 810.107(b) and shall not contain any special grades as defined in § 810.206.
Two-rowed Malting barley varieties not meeting the requirements of this section shall be graded in accordance with standards established for the
class Barley.
Larry Mitchell,
Administrator, Grain Inspection, Packers and
Stockyards Administration.
[FR Doc. 2014–17258 Filed 7–24–14; 8:45 am]
BILLING CODE 3410–KD–P
NUCLEAR REGULATORY
COMMISSION
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10 CFR Part 20
[NRC–2009–0279]
RIN 3150–AJ29
Radiation Protection
Nuclear Regulatory
Commission.
ACTION: Advance notice of proposed
rulemaking; request for comments.
AGENCY:
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The U.S. Nuclear Regulatory
Commission (NRC) is issuing this
advance notice of proposed rulemaking
(ANPR) to obtain input from
stakeholders on the development of a
draft regulatory basis. The draft
regulatory basis would support potential
changes to the NRC’s current radiation
protection regulations. The goal of this
effort is to achieve greater alignment
between the NRC’s radiation protection
regulations and the 2007
recommendations of the International
Commission on Radiological Protection
(ICRP) contained in ICRP Publication
103 (2007). Through this ANPR, the
NRC has identified specific questions
and issues with respect to a possible
revision of the NRC’s radiation
protection requirements. Stakeholder
comments, including responses to the
SUMMARY:
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specific questions, will be considered by
the NRC staff when it develops the draft
regulatory basis. In a separate and
related activity, the NRC staff will be
preparing an ANPR concerning the
NRC’s design objectives governing dose
assessments for radioactive effluents
from light-water-cooled nuclear power
reactors, which should be published for
public comment during the public
comment period for this ANPR. The
NRC plans to hold a series of public
meetings to promote full understanding
of the contemplated action and facilitate
public comment.
DATES: Submit comments by November
24, 2014. Comments received after this
date will be considered if it is practical
to do so, but the NRC is only able to
ensure consideration of comments
received on or before this date.
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules
You may submit comments
by any of the following methods (unless
this document describes a different
method for submitting comments on a
specific subject):
• Federal rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2009–0279. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–287–3422;
email: Carol.Gallagher@nrc.gov. For
technical questions contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Email comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
• Fax comments to: Secretary, U.S.
Nuclear Regulatory Commission at 301–
415–1101.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
• Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
(Eastern Time) Federal workdays;
telephone: 301–415–1677.
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:
Cardelia Maupin, Office of Federal and
State Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 301–415–
2312; email: Cardelia.Maupin@nrc.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2009–
0279 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2009–0279.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘ADAMS Public Documents’’ and then
select ‘‘Begin Web-based ADAMS
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Search.’’ For problems with ADAMS,
please contact the NRC’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The
ADAMS accession number for each
document referenced (if it is available in
ADAMS) is provided the first time that
it is mentioned in the SUPPLEMENTARY
INFORMATION section. 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: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC–2009–
0279 in the subject line of your
comment submission, in order to ensure
that the NRC is able to make your
comment submission available to the
public in this docket.
The NRC cautions you not to include
identifying or contact information in
comment submissions 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, and 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. Background
The NRC’s primary radiation
protection regulations are in part 20 of
Title 10 of the Code of Federal
Regulations (10 CFR). The purpose of
these regulations is to establish
standards of protection for both
members of the public and occupational
workers from ionizing radiation
resulting from activities conducted
under licenses issued by the NRC. These
standards are implemented through the
radiation protection requirements in the
10 CFR part 20 regulations that NRC
licensees must follow. The NRC’s
predecessor agency, the Atomic Energy
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43285
Commission (AEC), initially issued its
regulations for radiation protection in
the Federal Register (FR) on January 29,
1957 (22 FR 548). The regulations
substantially followed the
recommendations of the first official
publication of the then National
Committee on Radiation Protection and
Measurement, which was renamed in
1964 when it was officially charted by
the U.S. Congress (Pub. L. 88–376) and
is now known as the National Council
on Radiation Protection and
Measurements (NCRP). The NCRP
report was published in 1953 by the
Subcommittee on Permissible Internal
Dose, Handbook 52, ‘‘Maximum
Permissible Amounts of Radioisotopes
in the Human Body and Maximum
Permissible Concentrations in Air and
Water’’ (NCRP 1953).1 The ICRP
essentially adopted the NCRP 1953
recommendations in
‘‘Recommendations of the International
Commission on Radiological
Protection,’’ December 1, 1954,’’ except
for one major deviation. The ICRP was
the first to recommend limiting
radiation doses to persons other than
radiation workers, that is, to members of
the public. It recommended a dose one
tenth of that acceptable for occupational
workers, which the NCRP later adopted
in 1958.2
Throughout the mid to late 1950s, the
ICRP and the NCRP adopted similar
recommendations. For example, in
April 1956, the ICRP considered
changes to its dosimetry system that
included recommendations for
accumulated internal dose limits for the
critical organs of the human body. The
ICRP issued a recommendation of 50
mSv (5 rem) per year for the whole
body, gonads, lens of the eye, and active
bone marrow of occupational workers.
This recommendation was later adopted
by both the NCRP and the ICRP (NCRP
1957 and ICRP 1958).3 The AEC’s 1957
1 ‘‘A Review of the History of U.S. Radiation
Protection Regulations, Recommendations, and
Standards,’’ by C.G. Jones, Health Physics Journal,
February 2005, Vol. 88, No. 2, pages 105–126
(ADAMS Accession No. ML050400427), ‘‘1956
Report on Amendments during 1956 to the 1954
Recommendations of the International Commission
on Radiological Protection,’’ 1956, ICRP, and
‘‘Maximum Permissible Radiation Exposure to Man,
A preliminary statement of the National Committee
on Radiation Protection and Measurements,’’ 1957.
2 ‘‘1954 Recommendations of the International
Commission on Radiological Protection,’’ 1955, and
‘‘Permissible Dose: A History of Radiation
Protection in the Twentieth Century,’’ by Samuel
Walker, 2000, page 12.
3 The recommended ICRP reference format is:
‘‘Recommendations of the International
Commission on Radiological Protection, ICRP
Publication 1 (1959),’’ and the condensed reference
format used in this document is: ICRP Publication
1 (1959).
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules
final rule that promulgated 10 CFR part
20, and the 1960 amendments to 10 CFR
part 20 (25 FR 8595, September 7, 1960;
and 25 FR 10914, November 17, 1960),
reflect collaborative efforts between the
ICRP and NCRP. Therefore, the dose
calculation methodology for the AEC’s
radiation protection standards was
based, in part, upon the compilation of
the ICRP recommendations developed
during the mid to late 1950s and
contained in ICRP Publication 1,
‘‘Recommendations of the International
Commission on Radiological
Protection,’’ 1959; and ICRP Publication
2, ‘‘Permissible dose for internal
radiation,’’ 1959.
Following the establishment of the
NRC in 1975, the next and last revision
of 10 CFR part 20 was published in the
Federal Register on May 21, 1991 (56
FR 23360). The purpose of the 1991
revision was to adopt the basic tenets of
the ICRP system of radiation dose
limitation described in ICRP Publication
26 (1977), ‘‘Recommendations of the
ICRP.’’ 4 The 1977 recommendations
significantly modified previous
radiation protection concepts and
principles.
It established a new risk-based system
of radiation protection based on three
principles: Justification, optimization,
and limitation. (1) Justification requires
that no new practice or operation
involving radiation should be allowed
unless it produces a net benefit (i.e., no
frivolous use of radiation). (2)
Optimization requires all exposures to
be kept as low as is reasonably
achievable (ALARA) taking into account
all relevant social and economic factors.
(3) Limitation requires that the effective
dose equivalent to individuals shall not
exceed the limits (dose limits) as
established for appropriate
circumstances. The ICRP Publication 26
(1977) also provided for the summation
of internal and external exposures for
the first time, and eliminated the
concept of a threshold effect or
tolerance dose and introduced the
concept of carcinogenesis as a stochastic
effect (i.e., health effects that occur
randomly). It provided the foundation
and basis for all current Federal and
State regulations, except the U.S.
Department of Labor’s, which is still
based upon the ICRP recommendations
of the 1950s. (Reference: ‘‘A Review of
the History of U.S. Radiation Protection
Regulations, Recommendations, and
Standards,’’ by C.G. Jones, Health
Physics Journal, February 2005, Vol. 88,
4 The recommended ICRP reference format is:
‘‘ICRP, 1977. Recommendations of the ICRP. ICRP
Publication 26. Ann. ICRP 1 (3),’’ and the
condensed reference format used in this document
is: ICRP Publication 26 (1977).
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No. 2, page 113, (ADAMS Accession No.
ML050400427), and Radiation
Protection, Chapter 4, page 4–3, by J.U.
Burnham, et al, 1992)
The majority of the ICRP Publication
26 (1977) recommendations were
adopted in NCRP Report No. 91 (1987),
‘‘Recommendations on Limits for
Exposure to Ionizing Radiation.’’ The
1987 report replaced NCRP Report 39
(1971), ‘‘Basic Radiation Protection
Criteria,’’ and NCRP Report No. 43
(1975), ‘‘Review of the Current Status of
Radiation Protection Philosophy.’’
Therefore, the majority of the NCRP
Report No. 91 (1987) recommendations
were adopted in the 10 CFR part 20
amendments of 1991. The NCRP
recommendations were issued after the
publication of the proposed 10 CFR part
20 rule; as a result, some of its
recommendations were not adopted in
the final rule. For more information
about ICRP Publication 26 (1977) and
NCRP Report No. 91 (1987)
recommendations incorporated into 10
CFR part 20 final rule, please see the
statement of considerations for the 1986
proposed 10 CFR part 20 rule (51 FR
1092) and the 1991 final 10 CFR part 20
rule (56 FR 23391).
The 1991 revisions to 10 CFR part 20
were also supported by information in
ICRP Publication 30 (1979–1988),
‘‘Limits for Intakes of Radionuclides by
Workers,’’ 5 including its four parts, four
supplements and index, which were
published during the period of 1979
through 1988; and ICRP Publication 32
(1981), ‘‘Limits for Inhalation of Radon
Daughters by Workers.’’ These
documents were used to calculate the
inhalation values for the annual limits
on intake (ALIs) and derived air
concentrations (DACs) for the
radionuclides in 10 CFR part 20,
appendix B. For more information about
the application of these ICRP
publications to the 10 CFR part 20
amendments, please see the statement of
5 ICRP Publication 30 was published in four parts
and several supplements. These publications are:
‘‘ICRP, 1979. Limits for Intakes of Radionuclides by
Workers. ICRP Publication 30 (Part 1). Ann. ICRP
2 (3–4);’’ ‘‘ICRP, 1979. Limits for Intakes of
Radionuclides by Workers. ICRP Publication 30
(Supplement to Part 1). Ann. ICRP 3 (1–4);’’ ‘‘ICRP,
1980. Limits for Intakes of Radionuclides by
Workers. ICRP Publication 30 (Part 2). Ann. ICRP
4 (3–4);’’ ‘‘ICRP, 1981. Limits for Intakes of
Radionuclides by Workers. ICRP Publication 30
(Part 3). Ann. ICRP 6 (2–3);’’ ‘‘ICRP, 1982. Limits
for Intakes of Radionuclides by Workers. ICRP
Publication 30 (Supplement B to Part 3). Ann. ICRP
8 (1–3);’’ ‘‘ICRP, 1982. Limits for Intakes of
Radionuclides by Workers. ICRP Publication 30
(Index). Ann. ICRP 8 (4);’’ and ‘‘ICRP, 1988. Limits
for Intakes of Radionuclides by Workers: An
Addendum. ICRP Publication 30 (Part 4). Ann. ICRP
19 (4).’’ These publications are referenced
collectively in the condensed reference formats as
ICRP Publication 30 (1979–1988).
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considerations for the 1986 proposed 10
CFR part 20 rule (51 FR 1092, 1121) and
the 1991 final 10 CFR part 20 rule (56
FR 23391).
In ICRP Publication 45 (1985),6 ICRP
issued a statement recommending that
the annual dose limit for members of the
general public be reduced from 5 mSv
(500 mrem) to 1 mSv (100 mrem); this
annual dose limit which was adopted in
the NRC’s 1991 rulemaking.7 In
addition, when the 10 CFR part 20
rulemaking was near completion, the
ICRP developed a new series of
recommendations as ICRP Publication
60 (1991).8
The ICRP Publication 60 (1991)
recommendations included lowering the
occupational dose 9 limit from 50 mSv
(5 rem) per year to a 5-year average of
20 mSv (2 rem) per year, with the dose
in any given year not to exceed 50 mSv
(5 rem); eliminating dose limits for
individual organs, except for the skin
and the lens of the eye; lowering the
exposure limits to an embryo/fetus
during the gestation period from 5 mSv
(500 mrem) to 4.5 mSv (450 mrem); and
changing radiation protection
terminology and definitions. The ICRP
Publication 60 (1991) recommendations
were not considered in the NRC’s 1991
rulemaking because they were issued
after the rule’s public comment period
ended. Following the issuance of ICRP
Publication 60 (1991), the ICRP issued
a series of publications that revised
internal dosimetry models. The revised
internal dosimetry models superseded
many, but not all, of the models
described in ICRP Publication 30 (1979–
1988) and earlier ICRP publications. As
6 The recommended ICRP reference format is:
ICRP, 1985. Developing a Unified Index of Harm.
ICRP Publication 45. Ann. ICRP 15 (3), and the
condensed reference format used in this document
is: ICRP Publication 45 (1985).
7 International Commission on Radiological
Protection, ‘‘Statement from the 1985 Paris Meeting
of the ICRP,’’ British Journal of Radiology, Vol. 58,
page 910:1985: also; Health Physics, 45(6), pages
828–829 (June 1985).
8 The ICRP recommended format is: ICRP, 1991.
1990 Recommendations of the International
Commission on Radiological Protection. ICRP
Publication 60. Ann. ICRP 21 (1–3), and the
condensed reference format used in this ANPR is:
ICRP Publication 60 (1991).
9 The NRC’s regulations define ‘‘occupational
dose’’ as ‘‘the dose received by an individual in the
course of employment in which the individual’s
assigned duties involve exposure to radiation or to
radioactive material from licensed and unlicensed
sources of radiation, whether in the possession of
the licensee or other person. Occupational dose
does not include doses received from background
radiation, from any medical administration the
individual has received, from exposure to
individuals administered radioactive material and
released under § 35.75, from voluntary participation
in medical research programs, or as a member of the
public.’’ 10 CFR 20.1003 (definition of
‘‘occupational dose’’).
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a result, there are differences between
10 CFR part 20 and the dosimetry
approaches and occupational dose
limits reflected in ICRP Publications 60–
61, 66–69, 71–72, and 74.10
Other than conforming changes to
update cross-references to 10 CFR part
20 found in other NRC regulations, the
1991 rulemaking did not substantively
revise other NRC regulations (e.g., 10
CFR parts 32, 50, 51, 61, and 72) that
had explicit dose criteria. Consequently,
some NRC regulations are still based on
ICRP Publication 1 (1959), ICRP
Publication 2 (1959), and NCRP reports
of the 1950s. The differences between
the 10 CFR part 20 requirements and the
ICRP recommendations issued after
ICRP Publication 30 (1979–1988) have
created challenges for the NRC and its
licensees.
The NRC staff described these
challenges in its paper to the
Commission, 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,’’ dated August 2, 2001
(ADAMS Accession No. ML011580363).
Specifically, the challenges included
licensee requests to use dosimetry
methods based upon the
recommendations in the various ICRP
publications issued after ICRP
Publication 30 (1979–1988) for both
external (to the body) and internal
(within the body) dose assessments;
licensees exceeding, or potentially
exceeding, dose limits, although the
NRC staff had determined that in some
cases the 10 CFR part 20 methods for
assessing internal and external dose
were overly conservative relative to the
most current ICRP recommendations;
the general areas of differences between
radiation protection requirements of the
NRC and those nations that relied upon
the later ICRP recommendations,
including the differences in
10 ICRP Publication 61 (1991), ‘‘Annual Limits on
Intake of Radionuclides by Workers Based on the
1990 Recommendations;’’ ICRP Publication 66
(1994), ‘‘Human Respiratory Tract Model for
Radiological Protection;’’ ICRP Publication
67(1993), ‘‘Age-dependent Doses to Members of the
Public from Intake of Radionuclides—Part 2
Ingestion Dose Coefficients;’’ ICRP Publication 68
(1994), ‘‘Dose Coefficients for Intakes of
Radionuclides by Workers;’’ ICRP Publication 69
(1995), ‘‘Age-dependent Doses to Members of the
Public from Intake of Radionuclides—Part 3
Ingestion Dose Coefficients;’’ ICRP Publication 71
(1995), ‘‘Age-dependent Doses to Members of the
Public from Intake of Radionuclides—Part 4
Inhalation Dose Coefficients;’’ ICRP Publication 72
(1995), ‘‘Age-dependent Doses to the Members of
the Public from Intake of Radionuclides—Part 5
Compilation of Ingestion and Inhalation
Coefficients;’’ and ICRP Publication 74 (1996),
‘‘Conversion Coefficients for use in Radiological
Protection against External Radiation.’’
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occupational exposure limits; and the
use by some Federal agencies (e.g., U.S.
Department of Energy (DOE) and the
U.S. Environmental Protection Agency
(EPA)) of dosimetry models based upon
ICRP recommendations that were either
not incorporated in the 1991 rulemaking
or were published after that rulemaking.
The SECY–01–0148 paper also
discussed options for amending 10 CFR
part 20 by adopting the ICRP’s
recommended occupational dose limits,
dosimetric models, and related
parameters, and the advantages and
disadvantages of the NRC’s adoption of
the recommendations in ICRP
Publication 60 (1991) and the dosimetry
models in ICRP Publications 66–69, 71–
72, and 74. The paper concluded with
an NRC staff recommendation not to
amend 10 CFR part 20 at that time, but
rather to initiate an effort to study the
impacts of adopting the recommended
ICRP dosimetry models by through
outreach with stakeholders; working
with other Federal agencies through the
Interagency Steering Committee on
Radiation Standards (ISCORS) to ensure
a coherent approach within the United
States in radiation protection standards
and dosimetric models; developing a
technical information basis to provide a
better understanding of analytical
impacts of possible alternative changes
to 10 CFR part 20; and monitoring the
work of the ICRP as it develops its
revision to implement the ICRP
Publication 60 (1991) recommendations.
In the staff requirements
memorandum (SRM) to SECY–01–0148,
dated April 12, 2002, (ADAMS
Accession No. ML021050104), the
Commission approved the NRC staff’s
recommendations to continue to work
with and monitor the efforts of other
Federal agencies to ensure a coherent
approach to U.S. radiation protection
standards and dosimetric models and to
continue to monitor work of the ICRP.
The Commission disapproved the
development of a communication plan
and a technical information basis. The
Commission also directed the NRC staff
to continue to consider and grant, as
appropriate, licensee requests to use the
ICRP Publication 60 (1991) revised
internal dosimetry models on a case-bycase basis. As a result, the current NRC
regulatory framework is a mixture of
radiological standards, concepts and
quantities, ranging from the 1959
recommendations in ICRP Publication 1
(1959) to the modeling and numeric
values of the 1990 recommendations in
ICRP Publication 60 (1991).11
11 The NRC’s current 10 CFR part 20 regulations
do not expressly incorporate the recommendations
of ICRP Publication 60 (1991) but are based upon
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With the issuance of ICRP Publication
103 (2007),12 the NRC was again
presented with the question of whether
to update its regulations to reflect the
ICRP’s recommendations in the area of
radiation protection science. This
question was addressed in SECY–08–
0197, ‘‘Options to Revise Radiation
Protection Regulations and Guidance
with Respect to the 2007
Recommendations of the ICRP,’’ dated
December 18, 2008 (ADAMS Accession
No. ML091310193). This paper
described and evaluated the ICRP
Publication 103 (2007)
recommendations along with an NRC
staff’s recommendation that the
Commission approve a closer alignment
of the NRC’s regulatory framework with
the ICRP Publication 103 (2007)
recommendations. The NRC staff’s
recommendation set forth some steps to
achieve this alignment, including the
development of a technical basis, or the
rationale, for a proposed rulemaking to
amend the NRC’s radiation protection
regulations and outreach with
stakeholders and interested parties to
identify issues, options, and impact
information. The NRC staff stated that it
would provide the Commission with the
results of the stakeholder and interested
party interactions, the scope of the
proposed rulemaking, including policy
and implementation issues, the
resources needed for the rulemaking,
and the projected rulemaking
completion date, which would be
dependent on the ICRP’s development
of essential technical information.
The SECY–08–0197 paper noted that
the ICRP Publication 103 (2007)
recommendations provided new values
for the tissue weighting factors.13 The
paper also noted that ICRP estimated the
following dates and deliverables for
updated scientific information and
the recommendations of ICRP Publications 26 and
30. The NRC’s licensees must request use of the
ICRP Publication 60 (1991) internal dosimetry
models. If approved by the NRC, such a request is
treated as an exemption from 10 CFR part 20
regulations. The NRC’s authority to grant
exemptions is in 10 CFR 20.2301. As a matter of
practice, in such exemption approvals, the NRC
only authorizes the use of the dosimetric concepts
and quantities in the ICRP Publication 60 (1991)
recommendations.
12 The recommended ICRP reference format is
‘‘ICRP, 2007. The 2007 Recommendations of the
International Commission on Radiological
Protection. ICRP Publication 103. Ann. ICRP 37
(2–4), 2007.’’ The condensed ICRP reference format
used throughout this document is: ‘‘ICRP
Publication 103 (2007).’’
13 Weighting factor W for an organ or tissue (T)
T,
is the proportion of the risk of stochastic effects
(i.e., health effects that occur randomly) resulting
from irradiation of that organ or tissue to the total
risk of stochastic effects when the whole body is
irradiated uniformly (10 CFR 20.1003, definition of
‘‘Weighting factor WT’’).
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guidance for its new dosimetry system:
a. A dose conversion factors for
calculating occupational exposure from
the most commonly used radioisotopes
by 2011, b. dose conversion factors for
calculating dose limits for members of
the public by 2012, and c. dose
conversion factors for calculating
exposure for all radionuclides by 2014.
At present, this information is still being
developed. The ICRP’s development of
biokinetic and dosimetric models and
dose coefficients for both worker and
public exposure to radionuclides based
on the ICRP recommendations was
projected for completion by 2014. It is
anticipated that this information will
not be available until after 2015.
As pointed out in SECY–08–0197, the
revised dose conversion factors are
crucial to any amendment of the NRC’s
radiation protection framework. These
factors could provide the basis for
revising the numeric values of
weighting factors, ALIs, and DACs
contained in the following 10 CFR part
20 requirements: 10 CFR part 20,
appendix B, Table 1, ‘‘Occupational
Values;’’ 10 CFR part 20, appendix B,
Table 2, ‘‘Effluent Concentrations;’’ and
10 CFR part 20, appendix B, Table 3,
‘‘Releases to Sewers.’’
In the SRM to SECY–08–0197,
‘‘Options to Revise Radiation Protection
Regulations and Guidance with Respect
to the 2007 Recommendations of the
International Commission on
Radiological Protection,’’ dated April 2,
2009 (ADAMS Accession No.
ML090920103), the Commission
approved the NRC staff’s recommended
option to 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 ICRP Publication 103 (2007)
recommendations. The Commission also
directed the NRC staff to continue to
participate in national and international
forums on radiation protection and to
keep them informed of the results of
these outreach activities. Notably, the
Commission agreed with both the NRC
staff and the NRC’s Advisory Committee
on Reactor Safeguards (ACRS) that ‘‘the
current NRC regulatory framework
continues to provide adequate
protection of the health and safety of
workers, the public, and the
environment.’’ 14 In this regard, the
14 SRM–SECY–08–0197, ‘‘Options to Revise
Radiation Protection Regulations and Guidance
with Respect to the 2007 Recommendations of the
International Commission on Radiological
Protection,’’ dated April 2, 2009 (ADAMS
Accession No. ML090920103), at 1.
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Commission stated that from ‘‘a safety
regulation perspective, ICRP Publication
103 (2007) proposes measures that go
beyond what is needed to provide for
adequate protection.’’ 15 During the
outreach activities associated with the
potential alignment with the ICRP
Publication 103 (2007)
recommendations, the Commission
directed the NRC staff to ‘‘focus the
discussion on discerning the benefits
and burdens associated with revising
the radiation protection regulatory
framework.’’ 16
The Commission also directed the
NRC staff to examine how a lower
occupational dose limit of 20 mSv (2
rem) per year has affected the medical
and industrial sectors in countries that
have implemented the ICRP
recommendation when developing the
technical basis for the rulemaking.
Finally, based on the extent and
complexity of the stakeholder comments
received, the Commission directed the
NRC staff to either (1) provide the
Commission with a proposed rule once
the technical basis has been developed,
or (2) provide a paper to the
Commission outlining any substantive
policy issues and options for their
resolution prior to developing a
proposed rule.
In response to the Commission’s
direction in SRM–SECY–08–0197, NRC
staff conducted stakeholder outreach
activities on issues about potential
changes to the NRC’s radiation
protection regulations. Three Federal
Register notices were issued requesting
public feedback and comments (74 FR
32198, July 7, 2009; 75 FR 59160,
September 27, 2010; and 76 FR 53847,
August 30, 2011). Presentations and
discussions were made at a variety of
professional societies, licensee
organizations, public interest groups,
and State organizations (e.g., Conference
of Radiation Control Program Directors
and the Organization of Agreement
States).
In the fall of 2010, the NRC staff
conducted a series of facilitated round
table workshops in Washington, DC, Los
Angeles, CA, and Houston, TX. Each
workshop included representatives from
a broad range of users of radioactive
material; this process provided an
opportunity for various groups of
stakeholders to have a focused
discussion of the technical issues
associated with potential changes to the
NRC’s radiation protection standards.
The October 2010 workshop in
Washington, DC focused on the nuclear
power and fuel cycle industries and the
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16 Id.
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radiation protection programs of other
Federal agencies (e.g., EPA, DOE, U.S.
Navy, Armed Forces Radiobiology
Research Institute, and National
Institutes of Health). The November
2010 Los Angeles workshop focused on
medical uses of radiation, and the
November 2010 Houston, TX workshop
focused on industrial radiography.
These workshops provided stakeholders
the opportunity to discuss the various
technical issues with each other and
with NRC staff. Transcripts of each
workshop and written comments
received in response to the Federal
Register notices are publicly available
through the NRC’s public Web site on
the page entitled, ‘‘Options to Revise
Radiation Protection Regulations and
Guidance,’’ https://www.nrc.gov/aboutnrc/regulatory/rulemaking/potentialrulemaking/opt-revise.html.
In addition, the NRC staff’s outreach
activities included participation in the
revision of the International Basic Safety
Standards by the International Atomic
Energy Agency (IAEA) from 2009
through its completion in the second
quarter of 2013, and observation of the
revision of the Euratom Basic Safety
Standards Directive in the European
Union. Both the IAEA’s and Euratom’s
revisions focused on aligning their
requirements with the ICRP Publication
103 (2007) recommendations.
After extensive stakeholder
engagement, the NRC staff determined
that an additional paper to the
Commission outlining substantive
policy issues was needed. This
additional policy paper was provided as
SECY–12–0064, ‘‘Recommendations for
Policy and Technical Direction to
Revise Radiation Protection Regulations
and Guidance,’’ dated April 25, 2012
(ADAMS Accession No. ML121020108).
The SECY–12–0064 paper summarized
the NRC staff’s interactions with
stakeholders as directed by SRM–SECY–
08–0197, and provided policy and
technical guidance on potential
revisions to the NRC’s radiation
protection regulations.
In SECY–12–0064, the NRC staff
recommended that the NRC’s regulatory
framework be amended to reflect the
new terminology and dose calculation
methodologies to align with national
and international scientific approaches
for estimating radiation exposure and
risk contained in ICRP Publication 103
(2007). The NRC staff, however,
recommended that the NRC not initiate
a rulemaking to reflect these changes
until the ICRP published its updated
dose coefficients and other supporting
information, so that a single
comprehensive change could be made to
the relevant provisions and appendices
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of 10 CFR part 20. The NRC staff also
recommended that the following be
explored in greater detail: a reduction in
the occupational dose limit to 20 mSv
(2 rem) per year, including the
mechanisms that would be available to
provide some flexibility for licensees to
request a higher limit under specified
conditions; the impacts of a reduction in
the dose limit for the lens of the eye to
either 50 mSv (5 rem) or 20 mSv (2
rem), including how the prevention of
cataracts should be viewed in
comparison with the potential formation
of cancer or other adverse impacts; and
the impacts of a change in the dose limit
for the embryo/fetus to 1 mSv (100
mrem).
Finally, in SECY–12–0064, the NRC
staff recommended that: No additional
ALARA (as low as is reasonably
achievable) planning requirements
should be made, however applicable
regulatory guidance should be updated
to provide additional examples of
mechanisms acceptable in the
development and implementation of
radiation protection programs; the NRC
staff should continue to monitor and
interact with various international
organizations in developing tools and
methodologies for assessment of doses
in the environment; the NRC staff
should explore the implications,
benefits, and costs of aligning NRC
regulations in 10 CFR part 20 to the
NRC metrication policy; and the NRC
staff should explore a more detailed
examination of the implications,
benefits, and costs of requiring
additional NRC license categories and
Agreement State 17 licensees to report
occupational exposures to the NRC’s
Radiation Exposure Information and
Reporting System (REIRS) database.
In SRM–SECY–12–0064,
‘‘Recommendations for Policy and
Technical Direction to Revise Radiation
17 Section 274 of the Atomic Energy Act of 1954,
as amended (AEA), authorizes the NRC to
relinquish specified authority concerning the
regulation of certain radioactive materials to a State,
which then assumes regulatory authority over those
radioactive materials following the signing of a
written agreement between the NRC and the State.
Becoming an Agreement State is at the discretion
of the State; at present 37 states have Agreement
State status. Prior to such relinquishment, the NRC
must determine whether the proposed State
regulatory program is adequate to protect public
health and safety and is compatible with NRC’s
regulations before it can become an Agreement
State. Once Agreement State status is established,
the NRC will monitor the Agreement State program.
Amendments to NRC regulations may require
corresponding changes to the regulations of the
various Agreement States. The NRC’s Agreement
State regulations are in 10 CFR part 150. The
definitions section of 10 CFR part 150, 10 CFR
150.3, defines the term ‘‘Agreement State’’ as ‘‘any
State with which the [NRC] or the Atomic Energy
Commission has entered into an effective agreement
under subsection 274b of the [AEA].’’
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Protection Regulations and Guidance,’’
dated December 17, 2012 (ADAMS
Accession No. ML12352A133), the
Commission approved in part and
disapproved in part the NRC staff’s
recommendations. Specifically, the
Commission approved the NRC staff’s
development of a draft regulatory basis
for a revision to 10 CFR part 20 to align
with the most recent methodology and
terminology for dose assessment in ICRP
Publication 103 (2007), including
consideration of any conforming
changes to all NRC regulations. The
Commission directed the NRC staff to
develop improvements in the NRC’s
guidance for those segments of the
regulated community that would benefit
from more effective implementation of
the ALARA strategies and programs to
comply with regulatory requirements.
The Commission also directed the NRC
staff to continue discussions with
stakeholders regarding dose limits for
the lens of the eye and the embryo/fetus.
In addition, the Commission directed
the NRC staff to continue discussions
with stakeholders on alternative
approaches to deal with individual
protection at or near the current dose
limit. Finally, the Commission directed
the NRC staff to improve reporting of
occupational exposure by the NRC and
Agreement State licensees to the NRC’s
REIRS database.
In SRM–SECY–12–0064, the
Commission disapproved the NRC
staff’s recommendations to develop a
draft regulatory basis to reduce the
occupational total effective dose
equivalent to 20 mSv (2 rem) per year.
The Commission also disapproved the
elimination of traditional or ‘‘English’’
dose units to measure radiation
exposure from the NRC’s regulations.
Rather, the Commission directed the
continuation of the use of both
traditional and International System
(SI) 18 units in the NRC’s regulations.
In a separate and related activity, the
NRC staff will be preparing an ANPR for
10 CFR part 50, appendix I (RIN 3150–
AJ38; NRC–2014–0044), which concerns
the NRC’s design objectives governing
dose assessments for radioactive
effluents from light-water-cooled
nuclear power reactors. The preparation
of the 10 CFR part 50, appendix I, ANPR
is also in response to the Commission’s
direction in SRM–SECY–12–0064,
which stated that the NRC staff shall,
along with the development of the draft
regulatory basis for the 10 CFR part 20
regulations, engage in a parallel effort to
develop a draft regulatory basis for
18 ‘‘SI’’ is the French acronym for ‘‘Le Systeme
`
´
international d’unites’’ the modern form of the
metric system.
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43289
aligning the 10 CFR part 50, appendix
I, design objectives with the most recent
methodology and terminology for dose
assessment.19
III. Regulatory Objectives
In accordance with the Commission’s
direction provided in SRM–SECY–12–
0064, the NRC staff is preparing a draft
regulatory basis to support a possible
amendment to 10 CFR part 20, and with
conforming changes to other NRC
regulations to align more closely with
the ICRP Publication 103 (2007) dose
assessment methodology and
terminology. The NRC staff is
continuing to hold discussions with
stakeholders regarding alternative
approaches to ensure individual
protection at or near the current dose
limit are examined, including
considerations of whether revised or
additional regulatory requirements and
guidance may be appropriate to ensure
that cumulative occupational
exposures 20 are minimized, and
whether progressive restrictions should
be taken as cumulative exposures
increase; whether the dose limits for the
lens of the eye should be reduced;
whether the dose limits to the embryo/
fetus of a declared pregnant
occupational worker should be reduced;
and whether any undue hardships arise
as a result of applying the NRC’s
metrication policy to any amendment of
the 10 CFR part 20 regulations. The
results of these discussions with
stakeholders will be reflected in the
draft regulatory basis. Finally, the 10
CFR part 20 draft regulatory basis will
consider improvements in the reporting
of occupational exposure by the NRC
and Agreement State licensees,
including those licensees who currently
do not currently submit reports to the
NRC’s REIRS database.
IV. Specific Considerations
The NRC staff has identified policy
and technical issues to guide the
development of a draft regulatory basis
for the potential revisions to the NRC’s
radiation protection regulations and
guidance as described in Section III of
this ANPR. Sections A through F that
follow provide a summary of these
policy and technical issues. A more
detailed discussion of each issue is
19 The NRC staff has not yet determined whether
it will prepare one draft regulatory basis, covering
both potential revisions to the 10 CFR part 20
regulations and the 10 CFR part 50, appendix I,
design objectives, or two separate bases.
20 The total dose that an occupationally exposed
worker receives as a result of repeated exposures to
ionizing radiation to the same portion of the body,
or to the whole body, over time (https://
www.nrc.gov/reading-rm/basic-ref/glossary/
cumulative-dose.html).
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contained in a series of six issue papers
prepared by NRC staff and identified in
Section VIII of this ANPR.
A. Update 10 CFR Part 20 To Align With
ICRP Publication 103 Methodology and
Terminology
Several revisions are under
consideration to more closely align the
existing NRC regulations in 10 CFR part
20 with the ICRP Publication 103 (2007)
methodology and terminology for dose
assessment. During the 30-year period of
1977 to 2007, the ICRP published three
key radiological protection
recommendations, ICRP Publication 26
(1977), ICRP Publication 60 (1991), and
ICRP Publication 103 (2007). The
current NRC regulatory framework is a
mixture of radiological standards,
concepts and quantities ranging from
the recommendations in ICRP
Publication 1 (1959) to the modeling
and numeric values of the
recommendations in ICRP Publication
60 (1991).
The current 10 CFR part 20
regulations are based primarily upon the
recommendations of ICRP Publication
26 (1977); however, there is one
difference in terminology worth noting.
The ICRP recommendations used the
phrases ‘‘the sum of the dose-equivalent
from external exposure’’ and ‘‘the
committed effective dose equivalent
from the intake of radionuclides.’’ The
NRC’s regulations use the term ‘‘total
effective dose equivalent’’ (TEDE) to
represent the summation of dose
received from sources external to the
body and dose received from the intake
of radioactive materials.
In 1991, the ICRP revised its
recommendations for dose calculation.
The ICRP Publication 60 (1991)
recommendations provided changes in
the way tissue and radiation weighting
factors were defined and used (moving
from quality factors to radiation
weighting factors). A corresponding
change in terminology was also made.
For example, ICRP Publication 60 (1991)
introduced the term ‘‘effective dose,’’
which was defined as the sum of the
weighted equivalent doses in all the
tissues and organs of the body.
Additionally, the ICRP Publication
103 (2007) recommendations made
revisions to the calculation of dose,
including (1) modification of the
modeling used for calculation of
radiation exposures, (2) changes in
values of tissue weighting factors and
radiation weighting factors, and (3)
substantial modifications of the
metabolic models used to represent the
movement of radioactive material
through the human body. The human
body can now be modeled as a more
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complex set of mathematical and
‘‘voxel’’ 21 phantoms as a result of
advances in medical imaging technology
since the last substantial amendment of
the 10 CFR part 20 regulations in 1991.
These technological advances have
resulted in the development of reference
computational phantoms that are
specific models for adult males and
females, 15-year-old males and females,
and for various other age groups,
including infants, 1-year-old, 5-year-old,
and 10-year-old children. The reference
phantoms for the human body are
described in general terms in ICRP
Publication 103 (2007) and in ICRP
Publication 110 (2009).22
The availability of models for
different age groups provides the
opportunity to calculate the numeric
values for public exposure to effluents
in a more comprehensive manner as
compared to the previous calculation
methodology of basing assessments
primarily on an adult member of the
public. A general population includes
individuals of both genders and various
age groups that range from newborns to
senior citizens. Over time, an individual
matures from infancy to adulthood,
which includes various stages of
development. Therefore, the scientific
community is evaluating the
appropriate approach for a member of
the public that would account for the
period of time spent at different ages so
that the long-term risk of exposure to
radiological effluents over a number of
years can be properly represented. In
particular, the ICRP is considering the
use of an age and gender weighted dose
coefficient for developing a set of values
for environmental intake of
radionuclides. Similarly, the NRC is
also considering revising the definition
of the reference person 23 for its use in
environmental dose calculations. The
NRC is considering the use of the age
and gender averaged approach to
21 Voxel is the shortened term for volume pixel,
the smallest distinguishable box-shaped part of a
three-dimensional image. Voxel images are
primarily used in the field of medicine and are
developed from x-rays, CAT (Computed Axial
Tomography) scans, and MRIs (Magnetic Resonance
Imaging) allowing medical professionals to obtain
accurate 3D models of the human body. (Reference:
Webopedia (www.webopedia.com)).
22 The ICRP recommended format is: ICRP, 2009.
Adult Reference Computational Phantoms. ICRP
Publication 110. Ann. ICRP 39 (2), and the
condensed format used in this document is: ICRP
Publication 110 (2009).
23 The NRC’s regulations use the term ‘‘reference
man,’’ which means a hypothetical aggregation of
human physical and physiological characteristics
arrived at by international consensus. These
characteristics may be used by researchers and
public health workers to standardize results of
experiments and to relate biological insult to a
common base (10 CFR 20.1003, definition of
‘‘reference man’’).
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provide a more realistic representation
of a member of the public that explicitly
considers the presence of infants and
children within the population.
The concept of a reference person
may be like the approach documented
in the DOE Technical Standard, DOE–
STD–1196–2011, ‘‘Derived
Concentration Technical Standard,’’
dated April 2011 (ADAMS Accession
No. ML13323B598). The DOE–STD–
1196–2011 calculates derived
concentration standards using agespecific effective dose coefficients for
reference members of the public, along
with age and gender dependent intake
rates for ingestion of water and
inhalation of air. The members of the
public are represented by six age
subgroups (newborns,24 1-year-old,
5-year-old, 10-year-old, and 15-year-old
children and adults). The analysis
weights the effective dose coefficients
for each subgroup by their fractional
representation in the U.S. population
and by their intake of the radionuclide
through inhalation, ingestion, or air
submersion over their lifetimes. The
DOE standard is based on the weighting
factors and dose coefficients in ICRP
Publication 60 (1991).
As part of its development of the draft
regulatory basis, the NRC staff will
consider revising the regulations in 10
CFR part 20, as well as making
conforming changes to other NRC
regulations, to incorporate the ICRP
term, ‘‘effective dose.’’ The NRC staff
recognizes the preference, from a
regulatory stability standpoint, for
retaining the term ‘‘total effective dose
equivalent,’’ but will analyze, in the
draft regulatory basis, the advantages
and disadvantages of replacing ‘‘total
effective dose equivalent’’ with
‘‘effective dose’’ or ‘‘total effective dose’’
in its regulations.
The same terminology as it is used
elsewhere in the world may present
qualitative benefits of consistency and
ease in communication. With regard to
the ICRP’s dose assessment
methodology recommendations, the
NRC staff will consider, in the draft
regulatory basis, replacing the definition
of ‘‘weighting factor’’ (WT) in 10 CFR
20.1003 with the tissue weighting
factors in Table 3, ICRP Publication 103
(2007), and replacing the quality factors
in 10 CFR 20.1004, Tables (B).1 and
(B).2, ‘‘Units of Radiation Dose,’’ with
the radiation weighting factors in Table
2, ICRP Publication 103 (2007), along
with other associated changes (e.g.,
replacing ‘‘dose equivalent’’ with the
24 The DOE standard uses the term ‘‘newborn,’’
while ICRP Publication 103 (2007) uses the term
‘‘infant.’’
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term ‘‘equivalent dose,’’ and replacing
‘‘effective dose equivalent’’ with the
term ‘‘effective dose,’’ and revising the
definition of the term ‘‘quality factor’’).
If approved by the Commission, an
update of 10 CFR part 20 to reflect the
tissue weighting factors and radiation
weighting factors from ICRP Publication
103 (2007) would amend these sections.
In addition, as a part of the
development of the draft regulatory
basis, NRC staff will consider revising
the values in appendix B to 10 CFR part
20, ‘‘Annual Limits on Intake (ALIs) and
Derived Air Concentrations (DACs) of
Radionuclides for Occupational
Exposure; Effluent Concentrations;
Concentrations for Release to
Sewerage;’’ Table 1, ‘‘Occupational
Values;’’ Table 2, ‘‘Effluent
Concentrations;’’ and Table 3, ‘‘Releases
to Sewers,’’ with new values for ALIs,
DACs, effluent concentrations, and
sewer concentrations. The current
values in appendix B are based on a
public dose limit of 0.5 mSv (50 mrem).
The various types of NRC licenses
pose different challenges for the use of
methodology and terminology for dose
assessment. In some instances,
exposures to occupational workers and
members of the public at a licensed
facility are only from sources external to
the body. Conversely, other types of
licensed facilities have the potential for
significant exposures to occupational
workers and members of the public due
to intake of radionuclides. These types
of licenses would be more directly
impacted by the revision of the WT, ALI,
and DAC values. Therefore, the NRC
staff is seeking to understand how
various proposals for addressing this
issue would affect licensee activities.
Likewise, the NRC staff wishes to
understand the possible impacts of the
proposals, and more specifically, the
reasons why certain proposals may be
difficult to achieve or may undermine
radiation protection. Therefore, the NRC
staff is seeking to understand the
impacts of adopting the ICRP
Publication 103 (2007) methodology and
terminology into its regulatory program.
The Issue Paper 1, ‘‘Update 10 CFR
Part 20 to Align with International
Commission on Radiological Protection
Publication 103 Methodology and
Terminology,’’ ICRP Publication 103,
provides a more detailed discussion and
is available in ADAMS under Accession
No. ML14084A342. In addition, the
following questions are intended to
elicit information from the public, the
regulated community, and other
stakeholders.
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Questions
Q1–1: What are the implications of
changing the NRC’s regulations to
specify ‘‘total effective dose’’ in place of
the current term ‘‘total effective dose
equivalent?’’ To the extent possible,
please provide specific implementation
and operational cost information on the
impacts of this change relative to
licensee procedures, training,
recordkeeping, and reporting. This
information is necessary for the NRC to
determine whether the imposition of
such requirements on NRC licensees is
justified.
Q1–2: If the NRC adopts the dose
assessment terminology and
methodology of ICRP Publication 103
(2007) in a future rulemaking, what time
period should the NRC consider
providing for implementation of the
ICRP Publication 103 (2007)
methodology and terminology?
Q1–3: How should the calculations of
effluent concentration, currently in the
10 CFR part 20 radiation protection
regulations, be modified to reflect
advances in modeling that are now
available? In particular, the NRC is
interested in preliminary views on the
age and gender averaged approach.
Q1–4: Should the public dose limit of
0.5 mSv (50 mrem) continue to be the
basis for the effluent concentration
limits for the radionuclides in 10 CFR
part 20, appendix B, Table 2, Columns
1 and 2? Should it be reduced or
otherwise modified?
B. Occupational Dose Limit for the Lens
of the Eye
The ICRP Publication 26 (1977)
provided an occupational dose limit of
300 mSv (30 rem) per year for the lens
of the eye. During the 1980’s, it became
clear from epidemiological studies that
the risks from radiation exposure were
higher than those anticipated when the
ICRP Publication 26 (1977)
recommendations were published. As a
result, in ICRP Publication 60 (1991),
the ICRP recommended reducing the
occupational dose limit for the lens of
the eye to 150 mSv (15 rem) per year,
which is 50 percent of the previously
recommended limit of 300 mSv (30 rem)
per year in ICRP Publication 26 (1977).
In its 1991 rulemaking for 10 CFR part
20, the NRC adopted the ICRP
Publication 60 (1991) recommendation
in 10 CFR 20.1201(a)(2)(i). In addition,
the 1991 amendments added a
definition of ‘‘lens dose equivalent’’
(LDE), which is the external exposure of
the lens of the eye at a tissue depth of
0.3 cm (300 mg/cm2).25
25 10 CFR 20.1003, definition of ‘‘Lens dose
equivalent (LDE).’’
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As the ICRP continued to re-examine
its radiation protection principles, it
noted that the eye is one of the most
sensitive organs of the body, that the
protection of the eye against the effects
of ionizing radiation is designed
primarily to prevent the formation of
cataracts, and that the most sensitive
part of the eye for cataract formation is
the lens. Cataract formation falls under
the class of radiation effects referred to
as deterministic (or tissue reactions as
used in ICRP Publication 103 (2007)). At
doses above a certain threshold, the
severity of cataract formation increases
with dose, but the radiation-induced
incidence of cataract formation below
the threshold dose is believed to be
essentially zero.
On April 21, 2011, the ICRP issued a
statement on tissue reactions indicating
that a review of recent epidemiological
evidence suggests that there are some
tissue reaction effects, particularly those
with very late manifestation, where
threshold doses are, or might be, lower
than previously considered. For the lens
of the eye, the threshold absorbed dose
is now considered to be 0.50 Gy (50
rad). The ICRP’s statement was based on
draft report, ‘‘Early and Late Effects of
Radiation in Normal Tissues and
Organs: Threshold Doses for Tissue
Reactions and Other Non-Cancer Effects
of Radiation in a Radiation Protection
Context,’’ which was published on
January 20, 2011, by ICRP. The draft
report contained information reviewing
the early and late effects of radiation in
36 normal tissues and organs with
respect to radiation protection. It also
provided new estimates of threshold
doses for tissue injury in all organ
systems, and for morbidity and
mortality, following acute, fractionated,
or chronic exposure.
On, August 30, 2011, the NRC
solicited public comments on the
proposed new ICRP recommendations
with the publication, ‘‘New
International Commission on
Radiological Protection
Recommendations on the Annual Dose
Limit to the Lens of the Eye,’’ in the
Federal Register (76 FR 53847). A
summary of stakeholder views on this
issue is provided in SECY–12–0064,
Enclosure 3, ‘‘Assessment of Technical
Issues and Feedback,’’ pages 13 through
17 (ADAMS Accession No.
ML121020108).
The ICRP revised the January 2011
draft report based on the comments
received during the comment period. Its
findings were included in ICRP
Publication 118 (2012), ‘‘ICRP Statement
on Tissue Reactions and Early and Late
Effects of Radiation in Normal Tissues
and Organs—Threshold Doses for
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Tissue Reactions in a Radiation
Protection Context,’’ published on
August 28, 2012. The ICRP Publication
118 (2012) formalized the new ICRP
recommendations for the lens of the eye
that are based on the prevention of
radiogenic cataracts. For planned
occupational exposure situations, the
ICRP recommended reducing the limit
on equivalent dose for the lens of the
eye to 20 mSv (2 rem) per year, averaged
over 5 consecutive years (i.e., 100 mSv
(10 rem) in 5 years), with no single year
exceeding 50 mSv (5 rem), which is
significantly lower than ICRP’s previous
recommendation of 150 mSv (15 rem)
per year in ICRP Publication 60 (1991).
The NRC believes that it is
appropriate, and scientifically justified,
to explore in greater detail the impact of
a reduction in the dose limit for the lens
of the eye to 50 mSv (5 rem). The NRC
also believes that further discussion is
warranted on how the prevention of
cataracts (which can be corrected by a
well-established surgical procedure)
compares to efforts to reduce the
probability of cancer, a disease posing a
far greater health risk. The approaches
to be considered include adopting the
recommendations in ICRP Publication
118 (2012), moving towards closer
alignment with the ICRP
recommendations, or retaining the
current dose limit. Any new
requirements will have implications for
measuring occupational exposures and
the need to better estimate the dose to
the lens of the eye.
The Issue Paper 2, ‘‘Occupational
Dose Limit for the Lens of the Eye,’’
provides a more detailed discussion and
is available in ADAMS under Accession
No. ML14084A341. In addition, the
following questions are intended to
elicit information from the public, the
regulated community, and other
stakeholders to obtain this information.
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Questions
Q2–1: Is closer alignment with or
adoption of the ICRP Publication 118
(2012) recommendations regarding the
dose limits to the lens of the eye
appropriate given the scientific
information now available?
Q2–2: How should the impact of a
radiation-induced cataract be viewed in
comparison with other potential
radiation effects?
Q2–3: What mechanisms could be
applied to keep the cumulative
exposure to the lens of the eye below
the threshold of 0.50 Gy (50 rad)?
Q2–4: What methods should be
allowed for measurement or assessment
of the dose to the lens of the eye?
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Q2–5: What methods should be
allowed for recording dose to the lens of
the eye when the eyes are protected?
Q2–6: What are the potential
operational impacts of lowering the
annual occupational dose to the lens of
the eye from the current NRC regulatory
standard of 150 mSv (15 rem) to 50 mSv
(5 rem)? Would a reduction in the
occupational dose limit for the lens of
the eye require changes in programs,
procedures, practices (e.g., increased
use of protective eyewear), or in-room
shielding? If so, please describe these
changes, including any potential
implementation and operational costs.
Q2–7: What are the potential impacts
on State regulatory programs of a
reduction in the occupational dose limit
to the lens of the eye from the current
NRC regulatory standard of 150 mSv (15
rem) to 50 mSv (5 rem)?
C. Dose Limit for Embryo/Fetus of a
Declared Pregnant Occupational Worker
Currently, the NRC’s regulations in 10
CFR 20.1208(a) set the dose limit for the
embryo/fetus of a declared pregnant
worker at 5 mSv (500 mrem) for the
entire pregnancy. Section 20.1208(d)
provides allowances for delays in the
declaration of pregnancy by workers. If
the dose equivalent to the embryo/fetus
has exceeded 5 mSv (500 mrem), or is
within 0.5 mSv (50 mrem) of this dose,
at the time the worker declares the
pregnancy to the licensee, then the dose
to the embryo/fetus cannot exceed 0.5
mSv (50 mrem) for the remainder of the
pregnancy (10 CFR 20.1208(d)). In
addition, licensees are to make efforts to
avoid substantial variation above a
uniform monthly exposure rate to
satisfy the dose limit (10 CFR
20.1208(b)). These requirements are
based on the ICRP Publication 26 (1977)
recommendations. However, ICRP
Publication 103 (2007) recommends that
the dose limit for the embryo/fetus of a
declared pregnant worker be the same as
that for a member of the public, which
is 1 mSv (100 mrem).
Prior to the 1991 amendments to 10
CFR part 20, the NRC’s regulations did
not contain a specific dose limit for the
embryo/fetus of a declared pregnant
occupational worker. Instead, as a
matter of policy, the NRC used a single
annual limit for both genders and relied
on information in Regulatory Guide
8.13, ‘‘Instruction Concerning Prenatal
Radiation Exposure,’’ which was first
issued in March 1975 (ADAMS under
Accession No. ML13350A220) to
maintain exposures to the embryo/fetus
ALARA.
In developing Regulatory Guide 8.13,
the Commission considered the
recommendations in NCRP Report No.
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39 (1971), ‘‘Radiation Protection
Criteria.’’ The NCRP recommended that
during the entire gestation period, the
maximum permissible dose equivalent
to the embryo/fetus from occupational
exposure of the worker should not
exceed 5 mSv (500 mrem). The ICRP
Publication 26 (1977) recommended
limiting the working conditions of the
declared pregnant worker in such a
manner that it is unlikely that the
embryo/fetus would receive a dose
greater than 5 mSv (500 mrem) for the
entire gestation period (51 FR 1092;
January 9, 1986).
Thousands of pregnant women are
occupationally exposed to ionizing
radiation each year. There are radiationrelated risks throughout pregnancy that
are related to the stage of pregnancy and
absorbed dose. Exposure of the embryo/
fetus to ionizing radiation could cause
adverse health effects, such as cancer
and developmental abnormalities. The
susceptibility of the embryo/fetus to
damage by radiation is well established
and data suggests that the period from
10 weeks to 17 weeks in the
development of a fetus may be
especially critical. Because of this
susceptibility, limiting the dose to the
embryo/fetus to 5 mSv (500 mrem) or
less during the entire pregnancy is
generally considered desirable (51 FR
1092; January 9, 1986). Accordingly, the
NCRP Report 54 (1977), ‘‘Medical
Radiation Exposure of Pregnant and
Potentially Pregnant Women,’’
recommended that the total dose
equivalent to the embryo/fetus from
occupational exposure of the expectant
mother not exceed 5 mSv (500 mrem),
and that once the pregnancy is known,
exposure of the embryo/fetus not exceed
0.5 mSv (50 mrem) in any month.
The ICRP Publication 60 (1991) made
clear that the embryo/fetus should be
regarded as a member of the public
when considering the protection of
female workers who are or may be
pregnant. In ICRP Publications 60 (1991)
and 103 (2007), the ICRP concluded that
there is no reason to distinguish
between the genders for the purposes of
controlling occupational exposures.
However, under the ICRP
recommendations, if a female worker
declares her pregnancy, then additional
controls must be considered to protect
the embryo/fetus. The ICRP also stated
that the methods of radiation protection
for occupational workers, who are or
may be pregnant, should provide a level
of protection for the embryo/fetus
equivalent to that provided for a
member of the public. The ICRP
Publication 103 (2007) recommended
approach is that the working conditions
of a pregnant worker, after declaration
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of pregnancy, should be such that it is
unlikely that the additional dose to the
fetus would exceed about 1 mSv (100
mrem) during the remainder of
pregnancy.
On May 24, 2013, NCRP Report No.
174, ‘‘Preconception and Prenatal
Radiation Exposure: Health Effects and
Protective Guidance,’’ was released. It
updated and expanded upon the
information in NCRP Report No. 54. The
report noted that scientific knowledge
has increased and public concerns have
changed in the past 36 years since NCRP
Report No. 54 was published. Like the
findings of ICRP Publication 103 (2007),
the report recommended a dose limit of
1 mSv (100 mrem), including dose from
the intake of radionuclides, to the
embryo/fetus of a declared pregnant
worker and recommended applying the
concept of ALARA to these exposures.
Although the assessment of doses to
the embryo/fetus from exposures to
external radiation can be related directly
to exposures of the pregnant worker,
assessment of doses from intakes of
radionuclides is not straightforward.
Doses to the embryo/fetus may result
from the inhalation or ingestion of
radionuclides by the mother during or
before pregnancy, and additional doses
to the newborn child may result from
the transfer of radionuclides in breast
milk. The ICRP publications provide
dose coefficients for the offspring
(embryo/fetus and newborn child)
following radionuclide intake by the
mother before or during pregnancy and
during breast feeding. In many
important cases of potential
radionuclide intake, doses to the
offspring may exceed doses to the
mother; such cases should be taken into
account in the development of radiation
protection programs.26
To provide adequate radiation
protection for the embryo/fetus, and to
minimize the restriction on
employment, the NRC recognized the
importance of female workers
voluntarily informing their employers of
their pregnancy and the estimated date
of conception, so that arrangements can
be made to restrict potential exposures.
The pregnant worker has the
fundamental responsibility for deciding
when or whether she will formally
declare her condition to her employer.
This position is derived from court
rulings concerning a woman’s rights
regarding pregnancy. Having a formal
declaration of pregnancy derives from
26 See
ICRP Publication 60 (1991); ICRP
Publication 75 (1997), ‘‘General Principles for the
Radiation Protection of Workers;’’ and ICRP
Publication 96 (2005), ‘‘Protecting People against
Radiation Exposure in the Event of a Radiological
Attack.’’
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legal, not health protection,
considerations (56 FR 23373; May 21,
1991). If an occupational worker
chooses not to declare her pregnancy,
then the licensee will not be required
under the Commission’s regulations to
limit her dose to the 5 mSv (500 mrem).
The undeclared pregnant
occupational women are protected
under the NRC’s regulations for all
workers. The normal occupational dose
limits would still be in effect and would
have to be complied with, and the dose
would also have to be kept ‘‘as low as
is reasonably achievable.’’ In addition,
as part of her initial employment, the
woman, like all occupational workers,
should receive instructions in radiation
protection (10 CFR 19.12), and a copy of
the current version of Regulatory Guide
8.13 (56 FR 23373; May 21, 1991).
The ICRP Publication 103 (2007)
recommends that the dose to the
embryo/fetus of a declared pregnant
worker provide the same general level of
protection as that offered for a member
of the public, which is 1 mSv (100
mrem). The ICRP recommends applying
the 1 mSv (100 mrem) criterion after the
declaration of pregnancy by the
occupational worker.
The NRC has determined that it is
appropriate and scientifically justified
to explore whether to change the dose
limit for the embryo/fetus to 1 mSv (100
mrem). In its 1991 final rule that
amended 10 CFR part 20, the NRC
changed the dose limit for a member of
the public from 5 mSv (500 mrem) to 1
mSv (100 mrem); however, it did not
make the corresponding change to the
dose limit for the embryo/fetus.
Lowering the dose limit for the embryo/
fetus of a declared pregnant
occupational worker would align the
NRC’s regulatory requirements with
current scientific data. The data indicate
that the embryo/fetus is more sensitive
to radiation than initially surmised.
This approach would also align the
NRC’s regulations with the ICRP
Publication 103 (2007)
recommendations. The option of
applying the limit over the entire
gestation period, or only to the portion
of time following declaration, would
need to be explored in greater detail.
The Issue Paper 3, ‘‘Dose Limit for the
Embryo/Fetus of a Declared Pregnant
Occupational Worker,’’ provides a more
detailed discussion and is available in
ADAMS under Accession No.
ML14084A339. In addition, the
following questions are intended to
elicit information from the public, the
regulated community, and other
stakeholders to obtain this information.
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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? What are
the potential implementation and
operational costs?
Q3–2: Are there any benefits or
impacts associated with applying the
reduced dose limit over the entire
gestation period, or only to the period
after declaration?
Q3–3: Are there any anticipated
implementation impacts on
recordkeeping if the dose limit to the
embryo/fetus is lowered to 1 mSv (100
mrem)? What are the potential
implementation and operational costs?
Q3–4: Are there technological
implementation issues, such as limits of
detection, which would make adoption
of the ICRP Publication 103 (2007)
recommendation difficult in certain
circumstances?
Q3–5: Are there data on actual dose
distributions to the embryo/fetus of a
declared pregnant worker? What are the
trends for these data?
D. Individual Protection—ALARA
Planning
Each NRC licensee is required to
develop, document, and implement a
radiation protection program
commensurate with the scope and
extent of its licensed activities.27 In
addition to meeting expressed dose
limits, the NRC requires its licensees to
apply the ALARA principle to their
licensed operations. Section 20.1003
defines the term ALARA as ‘‘making
every reasonable effort to maintain
exposures to radiation as far below the
dose limits in this part [10 CFR part 20]
as is practical consistent with the
purpose for which the licensed activity
is undertaken . . .’’ 28 The NRC’s
current ALARA requirements are
provided in subpart B of 10 CFR part 20,
‘‘Radiation Protection Programs,’’ and
are contained in 10 CFR 20.1101(b) and
(d). The current occupational dose
limits are provided in subpart C of 10
CFR part 20, ‘‘Occupational Dose
Limits,’’ and 10 CFR 20.1201 provides
the occupational dose limits for adults.
In the United States, the majority of
occupationally exposed individuals
receive less than 20 mSv (2 rem) per
year as reported to the NRC.29 However,
27 10
CFR 20.1101(a).
CFR 20.1003 (definition of ‘‘ALARA
(acronym for ‘as low as is reasonably achievable’ ’’).
29 NUREG–0713, ‘‘Occupational Radiation
Exposure at Commercial Nuclear Power Reactors
and Other Facilities 2011’’ (ADAMS Accession No.
ML13095A191).
28 10
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a small percentage of individuals
receive larger exposures up to, and
occasionally above, the NRC’s current
annual occupational limit of 50 mSv (5
rem). While nuclear power reactor
operators have been successful in
reducing individual exposures, such
that only a very limited number of
individuals exceed 20 mSv (2 rem) in a
year,30 this is not the case in other
segments of the regulated community.
For example, industrial radiographers
have a somewhat greater percentage of
individuals above the average annual
dose level of 20 mSv (2 rem)
recommended in ICRP Publication 103
(2007). Stakeholder interactions have
led the NRC staff to conclude that some
of these individuals may be receiving
doses close to the 50 mSv (5 rem) limit
over multiple years. As described in
Section IV.E. of this ANPR and Issue
Paper 6, ‘‘Reporting of Occupational
Exposure’’ (ADAMS Accession No.
ML14084A344), detailed information on
these cumulative exposures is difficult
to ascertain because some segments of
the regulated community are not
required to report occupational
exposure, therefore making it difficult
‘‘to assure that lifetime exposure of
workers repeatedly exposed near the
limits is minimized’’ (52 FR 2822;
January 27, 1987).
The NRC’s regulation in 10 CFR
20.1101(b) provides that each licensee
‘‘shall use, to the extent practical,
procedures and engineering controls
based upon sound radiation protection
principles to achieve occupational doses
and doses to members of the public that
are as low as is reasonably achievable
(ALARA).’’ The NRC’s current
regulations in 10 CFR part 20 do not
include an explicit requirement to plan
activities to optimize radiation
protection (ALARA planning) or to
establish ALARA planning values as
part of the licensee’s radiation
protection program. With respect to
nuclear power reactors, the NRC staff
has issued Regulatory Guide 8.8,
Revision 3, ‘‘Information Relevant to
Ensuring that Occupational Radiation
Exposures at Nuclear Power Stations
Will Be As Low As Is Reasonably
Achievable’’ (ADAMS Accession No.
ML003739549), which describes
methods to implement the existing
ALARA requirements, including
detailed ALARA planning for use in the
operations of commercial power
reactors. However, this level of ALARA
planning is not as common in the
30 NCRP Report No. 160, ‘‘Ionizing Radiation
Exposure of the Population of the United States,’’
2009.
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programs of other types of NRC
licensees.
The NRC notes that its
implementation and enforcement of its
ALARA principles are generally made
through specific license conditions
instead of through more detailed
regulations. Therefore, the NRC staff
questions whether additional regulatory
requirements are appropriate to foster a
clear and consistent approach for all
types of licensees versus relying upon
license conditions.
In SRM–SECY–12–0064, dated
December 17, 2012 (ADAMS Accession
No. ML12352A133), the Commission
directed the NRC staff to continue
discussions with stakeholders on
alternative approaches to deal with
individual protection at or near the
current dose limit. The NRC is currently
examining possible mechanisms for
addressing individual protection at, or
near, the current occupational dose
limit of 50 mSv (5 rem) per year. One
potential mechanism for achieving this
goal is to revise 10 CFR 20.1101,
‘‘Radiation Protection Programs,’’ to
include additional requirements for
implementing ALARA. Furthermore,
reducing exposures through consistent
ALARA implementation is a straight
forward method for addressing concerns
about a worker receiving a cumulative
occupational dose, at or near the dose
limit, over a number of years.
In addition, the NRC is interested in
other proposals for addressing
individual protection at or near the
current dose limit. During previous
public interactions, some stakeholders
expressed an interest in strengthening
the current ALARA requirements,
whereas others expressed opposition to
any additional requirements. Some
stakeholders who opposed additional
ALARA requirements expressed
concerns that such additional
requirements would become de facto
limits and would inhibit the flexibility
of licensees to deal with specific
operational circumstances.
The NRC staff believes that the
objective of any additional regulatory
requirements should be to ensure the
accurate monitoring of an individual’s
cumulative occupational dose and to
ensure that progressive measures to
reduce dose are taken, if necessary, as
the cumulative dose increases. If the
NRC determines that additional
regulatory requirements are necessary to
limit the cumulative occupational dose,
then this objective could be achieved
through either performance-based
requirements, such as ALARA,
prescriptive requirements, or both.
Performance-based requirements
express or describe the particular
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outcomes that must be achieved while
leaving some discretion to a licensee on
the specific mechanisms used to achieve
those outcomes. On the other hand,
prescriptive requirements specify a
particular methodology or action that is
necessary for compliance.
The establishment of ALARA
planning values in administrative
control levels, relative to the
implementation of the ALARA
principle, is not a new concept. The
‘‘Federal Radiation Protection Guidance
for Occupational Exposure’’ (52 FR
2822, January 27, 1987; ADAMS
Accession No. ML13269A320), provides
a set of recommendations that
incorporates this concept. The NRC and
several other Federal agencies
developed these recommendations,
which were approved by President
Reagan on January 20, 1987. The
guidance states, ‘‘Federal radiation
guidance can address only the broad
prerequisites of an effective ALARA
program . . . authorities may find it
useful to establish or encourage the use
of . . . administrative control levels
specifying, for specific categories of
workers or work situations, dose levels
below the limiting numerical values
recommended in this guidance.’’
The current regulations do not require
licensees to have a structured ALARA
planning process. Therefore, the NRC is
considering the development of a
requirement for ALARA radiation
protection planning. This additional
ALARA planning requirement would
provide a basis to ensure that licensees
have an ongoing process to review
radiation exposures, to consider if
changes are warranted and practical to
reduce exposures, and to ensure the
implementation of appropriate
programmatic changes.
In conjunction with developing a
requirement for ALARA planning, the
NRC is considering developing a
mechanism to address additional
protection when an individual
occupational worker nears his or her
annual dose limit, and developing
cumulative dose criterion that would
control doses that an individual worker
may receive over a multiple-year period.
In this regard, the NRC would require
each licensee, as a part of its radiation
protection program, to establish
mechanisms to examine cumulative
occupational doses, and to implement
control measures limiting additional
doses if an occupational worker
approaches his or her cumulative dose
criterion. If the NRC ultimately issues
such a requirement, it would develop
associated guidance to address the
various types of licensed activities.
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Specifically, regulatory guidance
could describe the types of
methodologies that the NRC staff could
consider acceptable to meet the
regulatory requirement of controlling
dose as an individual occupational
worker approaches the annual dose
limit, or his or her cumulative dose
criterion. The NRC is considering using
various methodologies that are based on
national and international
recommendations. One potential
methodology could be for a licensee to
use the ICRP Publication 103 (2007)
recommendations for an average dose
over a 5-year period of 20 mSv (2 rem)
as an administrative control level
(ACL).31 If no individual at the licensed
facility exceeded the ACL on an annual
basis, then no additional actions would
be needed by the licensee other than
continued monitoring of exposures.
However, if an individual exceeded the
ACL in any particular year, the licensee
could commit to tracking and limiting
the dose of that worker over a 5-year
period; the licensee would need to
maintain the cumulative occupational
dose records during this period.
A second potential methodology for
establishing an ACL could be based on
the NCRP Report 116, ‘‘Limitation of
Exposure to Ionizing Radiation,’’ which
recommended an age based cumulative
dose restriction. The NCRP Report 116
recommended an occupational dose
limit of 50 mSv (5 rem) per year and a
cumulative occupational dose limit of
10 mSv (1 rem) times the individual’s
age in years. Therefore, a licensee could
establish an ACL at the 10 mSv (1 rem)
level, and if this level is exceeded in
any one year, the licensee would apply
cumulative dose tracking to ensure that
the cumulative age based dose limit for
the individual is not exceeded.
In a third potential methodology, a
licensee could establish an ACL based
on lifetime exposures instead of the
yearly approach to dose limits as in
ICRP or NCRP recommendations. Under
this approach, a licensee could commit
to tracking the cumulative occupational
doses for each worker and to applying
specific additional restrictions if the
cumulative occupational dose exceeded
a set lifetime cumulative ACL value.
Example values of cumulative ACL,
such as 0.5 Sv (50 rem) or 0.75 Sv (75
rem), over the worker’s lifetime could
31 The 1987 ‘‘Federal Radiation Protection
Guidance for Occupational Exposure’’ defines an
‘‘administrative control level’’ as a requirement
‘‘determined by a competent authority of the
management of an institution or facility. They are
not primary limits, and may therefore be exceeded,
upon approval of competent authority or
management, as situations dictate’’ (52 FR 2833;
January 27, 1987).
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serve as appropriate fractions of the
upper (tolerable) cumulative lifetime
dose limit found in ICRP and NCRP
recommendations. This approach could
work in conjunction with regulations for
cumulative occupational dose
recordkeeping requirements to ensure
that licensees took appropriate actions if
dose limits are exceeded.
The preceding methodologies are
presented as possible approaches for
implementing a general performance
requirement. Alternatively, the
regulation could specifically incorporate
one or more of these methodologies as
a new prescriptive requirement. The
NRC is interested in obtaining
stakeholder input on the use of a
performance or prescriptive approach,
the rationale as to why one approach is
preferable over the other, and any other
alternatives that the NRC should
consider as acceptable.
The NRC is also considering whether
an additional requirement is necessary
to address the question of concurrent
occupational doses of an individual
working at multiple licensed facilities.
Situations may occur in which workers
receive occupational exposures at more
than one facility concurrently. One
approach could be to expand the scope
of 10 CFR 20.2104(a) to cover workers’
concurrent employment by two or more
licensees during the same period of time
(e.g., a weekday shift at one licensee’s
facility followed by a weekend shift at
another licensee’s facility). Presently,
the regulations require licensees to
determine the yearly occupational doses
received by its workers. In this regard,
10 CFR 20.2104(c) could be revised to
add the phrase ‘‘and any concurrent’’ to
statements that now only specify the
individual’s most recent employer.
As discussed previously, before the
1991 amendments to 10 CFR part 20, the
NRC’s regulatory framework included
the formula D=5 (N–18), where ‘‘N’’ is
the person’s age in years, and where
‘‘D’’ is the lifetime dose limit in rems.32
As part of the implementation of this
former regulation, workers were
required to provide NRC Form 4,
‘‘Cumulative Dose History Report,’’
when reporting to a new facility.
However, the 1991 amendments to 10
CFR part 20 removed this requirement
and the lifetime dose limit formula. The
statement of considerations for the 1986
proposed rule (which led to the 1991
32 The former regulation, 10 CFR 20.101(b)(2),
stated ‘‘[t]he dose to the whole body, when added
to the accumulated occupational dose to the whole
body, shall not exceed 5 (N–18) rems where ‘N’
equals the individual’s age in years at his last
birthday.’’ The 1991 rulemaking revised and
renumbered the NRC’s radiation protection
regulations in 10 CFR part 20.
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final rule) explains the lifetime dose
limit formula was eliminated as a
measure to reduce annual and lifetime
doses to occupational workers (51 FR
1092, 1121; January 9, 1986). As a
result, there is now no requirement in
the NRC’s regulations for a licensee to
receive a cumulative dose history report
(NRC Form 4 or equivalent) from a new
employee.
The various types of radioactive
material licenses pose different
challenges to the control of occupational
doses (e.g., industrial radiography,
nuclear medicine). In some situations,
the design and operation associated
with the use of radioactive material
limits the occupational dose.
Conversely, some uses of radioactive
materials can result in significant
occupational doses that may be near the
annual dose limit. Therefore, the
spectrum of radioactive material
licenses presents a wide range of
challenges and opportunities for
reducing occupational doses under
ALARA provisions, especially when
exposures approach the limits. The NRC
is seeking to understand how to ensure
that a greater focus is placed on keeping
occupational doses ALARA, consistent
with the wide range of uses of
radioactive material that are licensed.
The NRC also seeks to understand the
potential impacts of the methodologies
that were previously discussed,
including any potential difficulties
associated with implementation if such
methodologies were made requirements
by rulemaking.
The Issue Paper 4, ‘‘Individual
Protection—ALARA Planning,’’
provides more detailed information and
is available in ADAMS under Accession
No. ML14084A340. In addition, the
following questions are intended to
elicit information from the public, the
regulated community, and other
stakeholders to obtain this information.
Questions
Q4–1: What are the potential
implications of adding specific ALARA
planning and implementation
requirements to the 10 CFR part 20
regulations? What changes to licensee
radiation protection programs could be
anticipated? What would be the
potential implementation and
operational costs?
Q4–2: What regulatory language
should be used for an additional
ALARA planning requirement and what
is the rationale for this language?
Q4–3: How does each of the described
methodologies for addressing when an
individual occupational worker
approaches his or her cumulative dose
for the year work for different classes of
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licensed uses (e.g., a worker at a nuclear
reactor power plant versus an industrial
radiographer versus medical personnel)?
What are the benefits and impacts of the
various approaches to ALARA planning
on the various types of licenses?
Q4–4: Should licensees be allowed to
establish different ACLs for different
groups of occupational workers? If so,
what should be the basis for the various
groupings?
Q4–5: How do the different
methodologies previously discussed
impact the ability of licensees to best
address radiation protection within
their programs?
Q4–6: Other than the methodologies
discussed in the preceding section, are
there other ways to evaluate
occupational lifetime cumulative
exposures that should be considered?
Q4–7: What are the potential impacts
to licensees, contractors, and dosimetry
vendors of amending 10 CFR 20.2104 to
require a licensee to account for
exposure from an occupational worker’s
concurrent employment with another
licensee? Are there any dosimetry
vendors that provide concurrent dose
records? Should the NRC consider
provisions that would require
individual occupational workers to
provide their occupational dose
information in addition to requiring
such information from licensees?
Q4–8: Should the Agreement States be
allowed to use more restrictive or
prescriptive requirements if the NRC
decides to use a performance-based
approach? What are the benefits and
impacts of the various methodologies
discussed in the preceding section on
Agreement State regulatory programs
and Agreement State licensees? If the
NRC issues a proposed rule, this
information will be important in
establishing an appropriate Agreement
State compatibility level for any
proposed regulatory requirements.
E. Metrication—Units of Radiation
Exposure and Dose
The current 10 CFR part 20 radiation
protection regulations were
promulgated approximately 1 year
before to the publication of the NRC’s
metrication policy (57 FR 46202;
October 7, 1992). The metric system is
also known as the International System
of Units (SI). Therefore, most NRC dose
limits and other units of measurements
are listed in the regulations with the
traditional or ‘‘English’’ (also known as
non-SI) units first followed by the
metric units in parentheses. Some NRC
regulations list metric units first
followed by traditional or ‘‘English’’
units in parentheses. Numerical
information in the appendices to 10 CFR
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part 20 is a mixture of traditional and
metric units. For example, the DACs in
10 CFR part 20, appendix B, Table 1, are
in units of microcuries per milliliter
(mCi/ml); therefore, the activity is in
traditional units and the volume is in
metric units. By contrast, appendix C of
10 CFR part 20 only displays numerical
information using the traditional units
of measurement.
In SRM–SECY–12–0064, the
Commission disapproved the
elimination of traditional units from the
NRC’s regulations. The SRM further
stated that both the traditional and SI
units should be maintained. Pursuant to
the NRC’s 1992 metrication policy, the
NRC supports and encourages the use of
the metric system of measurement by
the nuclear industry. The 1992 policy
directed the NRC staff, beginning in
1993, to publish the following
documents in dual units of
measurement with the SI units listed
first followed by the ‘‘English’’ units in
parentheses: New regulations, major
amendments to existing regulations,
regulatory guides, NUREG-series
documents, policy statements,
information notices, generic letters,
bulletins, and all written
communications directed to the public.
In addition, the NRC’s policy provided
that licensee-specific NRC documents,
such as licensee inspection reports and
licensee-specific docketed material, use
the system of measurements utilized by
the licensee. Furthermore, the policy
provided that all event reporting and
emergency response communications
between licensees, the NRC, and State
and local authorities will use the
traditional units of measurement. In a
1996 review of its 1992 metrication
policy, the Commission stated that it
does not intend to revisit the 1992
policy unless it is shown to cause an
undue burden or hardship (61 FR
31169, 31171; June 19, 1996).
The implementation of the NRC’s
metrication policy is not consistent with
respect to the units of measurement
used in recordkeeping and reporting.
The NRC’s regulations in 10 CFR
20.2101(a), ‘‘Records,’’ currently require
licensees to use the traditional units.
Therefore, licensees cannot use the
metric units even if they wanted to do
so. Section 20.2101(b) allows licensees
to record quantities in SI units in
parentheses after the traditional units.
Section 20.2101(c) requires information
recorded on shipping manifests, (e.g.,
shipments to low-level waste disposal
facilities) as required by 10 CFR
20.2006(b), to be listed in SI units or
both SI and traditional units. In
addition, some NRC regulations require
licensee reports to present information
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with the traditional units first followed
by the SI units in parentheses.
The requirement to keep all records in
traditional units, or in both sets of units,
could be seen as inconsistent with a
revised regulation in which the dose
criteria are expressed first in SI units
followed by the traditional units. One
alternative could be to amend the
regulations to allow a licensee to
maintain records in either set of units as
long as only one set of units was used
throughout a licensee’s recordkeeping
system. Another alternative could be to
allow a licensee to use either set of units
in measurements and calculations;
however, the licensee would be required
to present the final values that support
regulatory compliance in one or both
sets of units. These various alternatives
have different regulatory burdens and
implementation issues. The NRC staff is
seeking to gain additional information
from stakeholders on the implications of
the various alternatives, including the
option that no change should be made.
As part of its draft regulatory basis
development for a possible revision to
the 10 CFR part 20 regulations, the NRC
staff is examining the implementation of
the Commission’s metrication policy
about how numerical material could be
presented in appendix B of 10 CFR part
20. The NRC staff believes that the
unique nature of appendix B, with its
detailed numeric information for each
radionuclide, may pose a situation in
which a deviation from the metrication
policy may be needed.
Two issues need to be addressed
regarding the application of the
Commission’s metrication policy to
appendix B to 10 CFR part 20. The first
issue is the selection of the value that
the NRC will consider as the regulatory
standard. The values in appendix B are
currently given in traditional activity
units (microcuries (mCi)) with a
certainty of one significant digit. One
microcurie is equal to 3.7 × 104
becquerels (Bq) in the SI units;
therefore, the conversion from
microcurie to becquerel is completed by
multiplying the activity in microcuries
by 3.7 × 104. The resulting values in SI
units (becquerels) could be more or less
restrictive than the original microcurie
values depending on the number of
significant digits to which the value is
rounded. For example, currently
appendix B to 10 CFR part 20 provides
the oral ingestion ALI for Actinium-224
as 2 × 104 mCi. The corresponding value
in the SI units before rounding to one
significant digit is 7.4 × 107 Bq. If
rounded to one significant digit, using
the standard rounding conventions, the
value in Bq would be smaller than the
value in microcurie, and would be more
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restrictive. Therefore, the NRC staff is
exploring the implications of stating the
numerical values in appendix B of 10
CFR part 20 like that used in in
appendix A to 10 CFR part 37, ‘‘Physical
Protection of Category 1 and Category 2
Quantities of Radioactive Materials.’’
In the development of appendix A to
10 CFR part 37, the NRC stated that the
SI units provided the regulatory
standard and the traditional units were
provided for practical use only.
Appendix A to 10 CFR part 37 provides
in column 1 the name of the radioactive
material, column 2 provides the source
activity in terabecquerel (TBq), and
column 3 provides the source activities
in curies. In appendix A to 10 CFR part
37, the NRC also chose to forgo the
conventional rounding to the nearest
whole number or the rounding to the
first significant figure after the decimal
point. Rather, appendix A to 10 CFR
part 37, column 3 lists curie activity
equivalents as three significant figures
because many NRC licensees use curies
instead of becquerels for source
radioactivity. The 10 CFR part 37
-approach of rounding to three
significant figures greatly reduces any
discrepancies between the two values
(the source strength in curies and the
source strength in becquerels).
The second issue is the presentation
of numerical information in the
appendices to 10 CFR part 20. If the
NRC staff implements the Commission’s
metrication policy in appendix B to 10
CFR part 20 (i.e., SI units listed first
followed by traditional units in
parentheses), the table could become
more complicated. At present, appendix
B of 10 CFR part 20 consists of three
columns providing each radionuclide’s
name, symbol, and the solubility class,
followed by six additional columns
providing each radionuclide’s ALIs and
DACs, concentration limits for airborne
and liquid effluents released to the
general environment, and concentration
limits for discharges to sanitary sewer
systems in microcuries or microcuries
per milliliter. Implementation of the
metrication policy would effectively
add six additional columns to provide
the traditional unit numeric counterpart
for each value in parentheses next to the
corresponding values in the SI units. An
alternative could be to publish the
traditional unit values in a separate
guidance document for the convenience
of users; this alternative would an
exception to the Commission’s
metrication policy.
The NRC staff is interested in
stakeholder views on potential options
on the application of the Commission’s
metrication policy to any potential 10
CFR part 20 revisions. Specifically, the
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NRC staff is seeking input on: (1) What
are some of the potential options; (2)
what are the impacts of the option on
the format and the usefulness of the
NRC’s regulations; and (3) what are
some of the impacts of the option on
licensee operations, especially any
benefits, burdens, or undue hardship.
Using two units of measurements,
traditional and SI units has the potential
for causing communication challenges.
Therefore, the NRC staff is interested in
the implications and impacts of aligning
any potential revisions to 10 CFR part
20 with the Commission’s existing
metrication policy, and with other
possible changes that could be
considered as aligning to such a change.
The Issue Paper 5 ‘‘Metrication—
Units of Radiation Exposure and Dose,’’
provides more detailed information and
is available in ADAMS under Accession
No. ML14084A343. In addition, the
following questions are intended to
elicit information from the public, the
regulated community, and other
stakeholders.
Questions
Q5–1: Will promulgation of
amendments to the 10 CFR part 20
regulations with dose limits and other
measurements shown in dual units,
with the SI units shown first, followed
by the traditional units in parentheses,
cause an undue burden or hardship
upon any licensee or class of licensees?
If so, please explain and provide
examples, including any potential
implementation or operational costs.
Q5–2. Should 10 CFR 20.2101(a) be
revised to allow licensees the option of
providing records in SI units or in
traditional units? Should licensees be
allowed to provide reports in the units
used in licensee records? Should
licensees be required to record and
report in both sets of units? Please
provide reasons why or why not.
Q5–3. Should the NRC amend the
appendices for 10 CFR part 20 to show
values in SI units only, in traditional
units only, or in both sets of units? If
both SI and traditional units are
provided, which set of units should be
considered as the regulatory standard? If
only one set of units is specified, what
would be the most effective means to
provide the other set of units (e.g., in a
separate guidance publication)? Please
provide reasons why or why not.
F. Reporting of Occupational Exposure.
On December 19, 1968, the AEC
published an amendment to 10 CFR part
20 in the Federal Register (33 FR 18926)
that added new 10 CFR 20.407,
‘‘Personnel exposure and monitoring
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43297
reports.’’ 33 This new section required
the reporting of occupational radiation
exposure information to a central
repository at AEC headquarters. The
amendment required four categories of
licensees to report: (1) Commercial
nuclear power reactors, (2) industrial
radiographers, (3) fuel processors and
fabricators, and (4) manufacturers and
distributors of byproduct material. The
Commission considered these licensees
to have the greatest potential for
significant occupational doses. The AEC
established this reporting requirement
to assist in the following actions: (1)
Identifying those individuals who are
monitored by more than one licensee or
AEC contractor, (2) analyzing radiation
exposure experience and identifying
general exposure trends from year to
year, (3) analyzing the exposure
experience of AEC contractors and the
four listed categories of licensees, (4)
initiating appropriate remedial action
where trends or experience in increased
radiation exposures indicate the need
for more effective controls, and (5)
considering and developing appropriate
modifications to radiation protection
standards and requirements.
On January 19, 1975, the NRC was
formed and on May 30, 1975, the NRC
published a proposed rule in the
Federal Register (40 FR 23478) that
would require all NRC-specific licensees
to submit personnel monitoring data to
the agency. By a letter dated June 2,
1975 (43 FR 44827), a copy of the notice
of the proposed rule was mailed to all
NRC-specific licensees (e.g., well
loggers, medical and academic
institutions, industrial radiographers,
and portable gauge users). Thirty-six
comments were received on the
proposed rule. The majority of the
comments supported the proposed rule,
but offered suggestions for
improvement. Medical licensees raised
the majority of the opposition to the
proposed rule. Their opposition was
based on the following issues: (1)
Additional paperwork would increase
the cost of health care; (2) the personnel
monitoring data might have theoretical
value, but no practical value; (3) the
NRC failed to demonstrate a sufficient
cost versus benefit ratio for another
administrative requirement; (4)
occupational exposures (in medical
diagnosis and therapy) are already
ALARA; (5) the requirements for
33 In a final rule dated September 29, 1978 (43 FR
44827, 44829), the NRC renumbered 10 CFR 20.407
as 10 CFR 20.408. Section 20.408 later became the
basis for current 10 CFR part 20 reporting
regulation, 10 CFR 20.2206, which lists seven
categories of licensees required to submit an annual
report of the results of individual monitoring of
occupational exposure.
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reporting overexposures are adequate;
(6) only licensees with repeated
overexposures should be required to
submit annual reports; (7) separating
exposures received from NRC-licensed
material from exposures received from
non-NRC-licensed materials is not
possible; and (8) personnel monitoring
data contain inherent inaccuracies.
In response to these comments, in a
letter dated August 25, 1976, the NRC
requested that all NRC-specific licensees
voluntarily submit personnel
monitoring data for calendar year 1975,
along with the total cost for preparing
the data in man-hours and dollars-cents.
The licensees’ responses indicated a
total man-hours cost median of 2.75
minutes, and $0.65 per monitored
individual to collect the requested
information (NUREG–0419,
‘‘Occupational Radiation Exposure at
NRC-Licensed Facilities 1975, Office of
Standards Development, U.S. Nuclear
Regulatory Commission’’).
After a series of amendments in the
1980s, the occupational reporting
requirements in 10 CFR part 20
eliminated the provisions for all NRCspecific licensees to submit reports, and
expanded the license reporting
categories from four to the current
seven, which are: (1) Commercial
nuclear power reactors, (2) industrial
radiographers, (3) fuel processors and
fabricators, (4) manufacturers and
distributors of certain byproduct
material, (5) geologic repositories for
high-level waste (HLW), (6)
independent spent fuel storage
installations (ISFSIs) and (7) facilities
for the land disposal of low-level waste
(LLW) (46 FR 13978, February 25, 1981;
46 FR 58282, December 1, 1981; and 47
FR 57480, December 27, 1982).
The current occupational reporting
provisions were moved to 10 CFR
20.2206, ‘‘Reports of Individual
Reporting,’’ as a part of the 1991
amendments to 10 CFR part 20. Section
20.2206 requires seven categories of
licensees to provide an annual report of
the monitoring of occupational dose
each April 30th (covering the prior
calendar year) to the NRC’s REIRS
database. At present, five categories of
NRC licensees report information to the
database, namely: (1) Commercial
nuclear power reactors; (2) industrial
radiographers; (3) fuel processors
(including uranium enrichment
facilities), fabricators, and reprocessors;
(4) ISFSIs; and (5) manufacturers and
distributors of certain byproduct
material. The NRC’s REIRS database
does not include occupational
information for the two other reporting
categories, LLW and HLW facilities,
because the NRC has no licensees in
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those categories. As a result, the
database provides a system for
maintaining all relevant occupational
doses received at nuclear power
reactors, fuel processors and fabricators,
and ISFSIs in the United States, because
all of these facilities are licensed by the
NRC regardless of whether they are
(even if located in an Agreement State).
Currently, a reporting gap exists
because industrial radiographers, and
manufacturers and distributors of
certain byproduct material, who hold
Agreement State licenses, instead of
NRC licenses, are not subject to the
reporting requirements in 10 CFR
20.2206. As described in the following
paragraphs and Section VII.B., Issue
Paper 6, ‘‘Reporting of Occupational
Exposure’’ (ADAMS Accession No.
ML14084A344), Agreement States are
not required to adopt the provisions in
10 CFR 20.2206. Consequently, the NRC
has experienced significant difficulty in
developing reasonable assessments of
the overall occupational doses received
from industrial radiographers, and
manufacturers and distributors of
certain byproduct material, since the
majority of these licensees are regulated
by Agreement States. In addition, as
identified in the chart in Section V of
Issue Paper 6, several categories of NRC
radioactive material licensees are not
subject to the 10 CFR 20.2206 reporting
requirements. Therefore, the NRC lacks
occupational exposure data for several
categories of radioactive material
licensees.
The NRC’s regulations in 10 CFR
20.2206(b) require certain categories of
NRC licensees to submit an annual
report of the results of the monitoring
required by 10 CFR 20.1502 to the
NRC’s REIRS database. The NRC does
not require Agreement States to adopt
the 10 CFR 20.2206 provisions.
Although an Agreement State can
choose not to require their licensees to
submit annual reports of occupational
radiation dose information to either
itself or the NRC, some Agreement State
licensees voluntarily report
occupational dose information to the
REIRS database.
In addition, to expand the Agreement
State occupational radiation dose
information contained in the NRC’s
REIRS database, on August 6, 2010, the
NRC sent a letter to Agreement State
Radiation Control Programs (ADAMS
Accession No. ML102100390). This
letter requested Agreement State
assistance in obtaining occupational
radiation dose information from their
licensees in the categories of industrial
radiography and nuclear pharmacy for
the monitoring period of 2000 through
2009.
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During the period of 1997 through
2010, the NRC received occupational
dose reports from 312 Agreement State
licensees. The 312 licensees represented
less than 2 percent of the total number
of Agreement State licensees, at that
time. The NRC staff review of the
reports indicated that the 312
Agreement State licensees monitored
exposures of 40,622 occupational
workers, and 78 percent (31,704) of
these occupational workers received a
measurable dose. The complete NRC
staff review is available in NUREG–
2118, Vol.1, ‘‘Occupational Radiation
Exposure at Agreement State-Licensed
Materials Facilities, 1997–2010’’
(ADAMS Accession No. ML12220A081).
Increased use of the NRC’s REIRS
database, could serve as a national
occupational exposure database for both
the NRC and Agreement States. If
properly implemented, the database
could correlate the occupational
exposure of an individual to the
licensed facility where the exposure was
received. This information would be
especially useful for those workers who
work concurrently at more than one
licensed facility, especially in the
radioactive materials area. All of the
nuclear power plant licensees are
regulated by the NRC, and are required
to report occupational exposures to the
NRC’s REIRS database. Therefore, it is
possible to determine the occupational
doses of nuclear workers that are
employed at more than one nuclear
facility, including determining whether
a person is exceeding the occupational
dose limits. However, there is no
mechanism for the NRC or an
Agreement State to determine whether
an individual is exceeding the
occupational dose limits as a result of
concurrent employment at multiple
licensed facilities, especially if the
individual works in jurisdictions
regulated by both the NRC and one or
more Agreement States.
For example, a physician whose
medical practice involves the use of
radioactive materials could work
concurrently in Washington, DC (an
NRC jurisdiction), Alexandria, VA (an
Agreement State jurisdiction), and
Bethesda, MD (a different Agreement
State jurisdiction). If Agreement State
licensees provided reports to the NRC’s
REIRS database, then it would be
possible to ensure that an individual
who is concurrently employed by
licensees in multiple jurisdictions does
not exceed the occupational dose limits.
Moreover, increased use of the NRC’s
REIRS database by NRC and Agreement
State licensees, could serve a vital
function in evaluating the overall
effectiveness of the NRC’s regulatory
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programs, and could be used by the
NRC and Agreement States in
inspection, enforcement, and incident
response activities. It could also assist
in assessing cumulative occupational
doses on a national basis. The NRC staff
is considering if new categories of
licensees should be required to report to
the database and how to effectively
integrate any new reporting from NRC
and Agreement State licensees into the
system. Therefore, the NRC staff is
pursuing that a more detailed
examination of the implications,
benefits, and costs of requiring
additional categories of licensees to
report exposures to the NRC’s REIRS
database. The Issue Paper 6, ‘‘Reporting
of Occupational Exposures,’’ provides a
more detailed discussion of the
background and proposals on the
reporting of occupational doses to the
database including a chart in Section V
that lists several categories of NRC
radioactive material licensees where
input is needed from the public. In
addition, the following questions are
intended to elicit information from the
public, the regulated community, and
other stakeholders.
emcdonald on DSK67QTVN1PROD with PROPOSALS
Questions
Q6–1: What criteria should the NRC
use to identify additional categories of
licensees that should be required to
submit annual occupational exposure
reports under 10 CFR 20.2206(a)?
Q6–2: What are the benefits of
collecting occupational exposure
information in one central database to
assess the total annual occupational
exposure of those individuals who work
at more than one licensed facility or
contractor facility during the calendar
year and receive occupational exposures
at these facilities?
Q6–3: Should Agreement States be
required to adopt regulations that are
compatible with the requirements in 10
CFR 20.2206?
Q6–4: Should the NRC consider a
gradual expansion of the 10 CFR
20.2206 licensee reporting categories in
a step-wise fashion (e.g., staggered
compliance dates for different categories
of licensees)? What are the advantages
or disadvantages for this option?
Q6–5: What are the potential
implementation and operational costs
associated with expanding the
occupational exposure reporting
requirements?
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V. Public Meetings
The NRC plans to hold a series of
Category 3 public meetings specific to
the six issues identified in this ANPR.
The public meetings will be held during
the ANPR public comment period. The
public meetings will provide forums for
the NRC staff to discuss the issues and
questions identified in the ANPR with
external stakeholders and to receive
information to support development of
a draft regulatory basis for a potential
revision of the radiation protection
requirements in 10 CFR part 20. The
NRC does not intend to provide detailed
responses to comments or other
information submitted during the public
meetings. Each public meeting will be
noticed on the NRC’s public meeting
Web site at least 10 calendar days before
the meeting. Stakeholders should
monitor the NRC’s public meeting Web
site for additional information about the
public meetings at https://www.nrc.gov/
public-involve/public-meetings/
index.cfm. The NRC will post the
notices for the public meetings and may
post additional material related to this
action to the Federal rulemaking Web
site at www.regulations.gov under
Docket ID NRC–2009–0279. The Federal
rulemaking Web site allows you to
receive alerts when changes or additions
occur in a docket folder. To subscribe:
(1) Navigate to the docket folder (NRC–
2009–0279); (2) click the ‘‘Sign up for
Email Alerts’’ link; and (3) enter your
email address and select how frequently
you would like to receive emails (daily,
weekly, or monthly).
VI. Cumulative Effects of Regulation
The NRC has implemented a program
to address the possible ‘‘cumulative
effects of regulation’’ (CER) in the
development of regulatory bases for
rulemakings. The CER describes the
challenges that licensees or other
impacted entities (such as Agreement
States) may face while implementing
new NRC or other agency regulatory
requirements. The CER is an
organizational effectiveness challenge
that results from a licensee or other
impacted entity implementing a number
of complex positions, programs, or
requirements within a prescribed
implementation period and with limited
available resources, including the ability
to access technical expertise to address
a specific issue. The NRC is specifically
requesting comment on the cumulative
effects that may result from a potential
amendment to 10 CFR part 20. In
PO 00000
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Sfmt 4702
43299
developing comments on the possible
cumulative effects of any future 10 CFR
part 20 rulemaking, please consider the
following questions:
(1) In light of any current or projected
CER challenges, what could be
considered as a reasonable effective
date, compliance date, or submittal
date(s) from the time any potential final
rule is published to the implementation
date of any new requirements, including
changes to programs, procedures, or
facilities?
(2) If there are current or projected
CER challenges, what could be done to
address them (e.g., if more time is
anticipated to implement the potential
new requirements, what period of time
is estimated to be sufficient, and why
would such a proposed time frame be
necessary)?
(3) Please identify any current or
projected regulatory actions by the NRC
or another regulatory agency (such as
new or amended regulatory
requirements or orders) that could
potentially influence the
implementation of any potential 10 CFR
part 20 rulemaking?
(4) Are there any possible unintended
consequences resulting from a potential
10 CFR part 20 rulemaking, such as the
possibility that this potential
rulemaking could create conditions that
would be contrary to the potential
action’s purpose and objectives? If so,
what are the anticipated consequences
and how could they be addressed?
(5) Is there any potential costs and
benefits information available at this
time on a potential 10 CFR part 20
rulemaking?
VII. 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 ANPR to be consistent with
the Plain Writing Act as well as the
Presidential Memorandum, ‘‘Plain
Language in Government Writing,’’
published June 10, 1998 (63 FR 31883).
The NRC requests comment on this
ANPR and the draft regulatory basis
issues papers (see Section VIII of this
ANPR) with respect to the clarity and
effectiveness of the language used.
VIII. 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.
E:\FR\FM\25JYP1.SGM
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43300
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules
Document
ADAMS accession No./Web link
The ICRP Publications referenced in this ANPR are copyright protected. The NRC cannot reproduce or
provide copies of these documents. For additional information regarding obtaining copies of ICRP
Publications, please see the ICRP Web site.
The NCRP Publications referenced in this ANPR are copyright protected. The NRC cannot reproduce
or provide copies of these documents. For additional information regarding obtaining copies of NCRP
Publications, please see the NCRP Web site.
Issue Paper 1: Update 10 CFR Part 20 to Align with International Commission on Radiological Protection Publication 103 Methodology and Terminology.
Issue Paper 2: Occupational Dose Limit for the Lens of the Eye ...............................................................
Issue Paper 3: Dose Limit for the Embryo/Fetus of a Declared Pregnant Occupational Worker ...............
Issue Paper 4: Individual Protection—ALARA Planning ..............................................................................
Issue Paper 5: Metrication—Units of Radiation Exposure and Dose ..........................................................
Issue Paper 6: Reporting of Occupational Exposure ...................................................................................
A Review of the History of U.S. Radiation Protection Regulations, Recommendations, and Standards,’’
by C.G. Jones, Health Physics Journal, February 2005, Vol. 88, No. 2, pages 105–126.
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,’’ dated August
2, 2001.
SRM–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,’’ dated April
12, 2002.
SECY–08–0197, ‘‘Options To Revise Radiation Protection Regulations And Guidance With Respect To
The 2007 Recommendations of ICRP,’’ dated December 18, 2008.
SRM–SECY–08–0197, ‘‘Options To Revise Radiation Protection Regulations And Guidance With Respect To The 2007 Recommendations of ICRP,’’ dated April 2, 2009.
SECY–12–0064, ‘‘Recommendations For Policy And Technical Direction To Revise Radiation Protection Regulations And Guidance,’’ dated April 25, 2012.
SRM–SECY–12–0064, ‘‘Recommendations For Policy And Technical Direction To Revise Radiation
Protection Regulations And Guidance,’’ dated December 17, 2012.
Regulatory Guide 8.8, Revision 3, ‘‘Information Relevant to Ensuring that Occupational Radiation Exposures at Nuclear Power Stations Will Be as Low as Is Reasonably Achievable’’.
DOE Technical Standard, DOE–STD–1196–2011, ‘‘Derived Concentration Technical Standard’’ .............
‘‘Federal Radiation Protection Guidance for Occupational Exposure’’ (52 FR 2822; January 27, 1987) ...
Regulatory Guide 8.13 ‘‘Instruction Concerning Prenatal Radiation Exposure,’’ March 31, 1975 ..............
NUREG–0713, ‘‘Occupational Radiation Exposure at Commercial Nuclear Power Reactors and Other
Facilities 2011’’.
NUREG–2118, ‘‘Occupational Radiation Exposure at Agreement State-Licensed Materials Facilities,’’
1997–2010.
emcdonald on DSK67QTVN1PROD with PROPOSALS
X. Rulemaking Process
The NRC will consider comments
received or other information submitted
in response to this ANPR in the
development of the proposed draft
regulatory basis or any other documents
developed as a part of any potential 10
CFR part 20 rulemaking. The NRC,
however, does not intend to provide
detailed responses to comments or other
information submitted in response to
this ANPR. The information obtained
through this ANPR process will be used
to develop a draft regulatory basis. The
draft regulatory basis will be published
for public review and comment. If the
NRC develops a regulatory basis
sufficient to support a proposed rule,
then there will be an opportunity for
public comment when the proposed
rule is published and the NRC will
respond to such comments if and when
it publishes a final rule. If the NRC
develops draft supporting guidance for
a proposed 10 CFR part 20 rulemaking,
then the public, the regulated
community, and other stakeholders will
have an opportunity to provide
comment on the draft guidance.
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If the NRC decides not to pursue a 10
CFR part 20 rulemaking on this topic,
the NRC will publish a document in the
Federal Register that will generally
address public comments and withdraw
this ANPR.
Dated at Rockville, Maryland, this 8th day
of July 2014.
For the Nuclear Regulatory Commission.
Mark A. Satorius,
Executive Director for Operations.
[FR Doc. 2014–17252 Filed 7–24–14; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF ENERGY
[Docket No. EERE–2009–BT–BC–0021]
10 CFR Part 460
Appliance Standards and Rulemaking
Federal Advisory Committee
(ASRAC)—Manufactured Housing
Working Group
Office of Energy Efficiency and
Renewable Energy, Department of
Energy.
ACTION: Notice of open meeting.
AGENCY:
PO 00000
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https://www.icrp.org/publications.asp.
https://www.ncrponline.org/Publications/
Publications.html.
ML14084A342.
ML14084A341.
ML14084A339.
ML14084A340.
ML14084A343.
ML14084A344.
ML050400427.
ML011580363.
ML021050104.
ML083360555.
ML090920103.
ML121020108.
ML12352A133.
ML003739549.
ML13323B598.
ML13269A320.
ML13350A220.
ML13095A191.
ML12220A081.
This notice announces an
open meeting for the Manufactured
Housing Working Group (MH Working
Group). The purpose of the working
group will be to discuss and, if possible,
reach consensus on a proposed rule for
the energy efficiency of manufactured
homes, as authorized by section 413 of
the Energy Independence and Security
Act of 2007 (EISA).
SUMMARY:
A two-day, open meeting will be
held on:
Monday, August 4; 9 a.m.–5 p.m.
(EDT) and
Tuesday, August 5; 9 a.m.–5 p.m.
(EDT).
Foreign national wishing to
participate in the meeting must respond
by email to asrac@ee.doe.gov as soon as
possible, but no later than Monday, July
28, 2014, to initiate the necessary
security screening procedures.
DATES:
U.S. Department of Energy,
Forrestal Building, 1000 Independence
Avenue SW., Washington, DC 20585,
Room 8E–089. Individuals will also
have the opportunity to participate by
webinar.
ADDRESSES:
E:\FR\FM\25JYP1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Proposed Rules]
[Pages 43284-43300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17252]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Part 20
[NRC-2009-0279]
RIN 3150-AJ29
Radiation Protection
AGENCY: Nuclear Regulatory Commission.
ACTION: Advance notice of proposed rulemaking; request for comments.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing this
advance notice of proposed rulemaking (ANPR) to obtain input from
stakeholders on the development of a draft regulatory basis. The draft
regulatory basis would support potential changes to the NRC's current
radiation protection regulations. The goal of this effort is to achieve
greater alignment between the NRC's radiation protection regulations
and the 2007 recommendations of the International Commission on
Radiological Protection (ICRP) contained in ICRP Publication 103
(2007). Through this ANPR, the NRC has identified specific questions
and issues with respect to a possible revision of the NRC's radiation
protection requirements. Stakeholder comments, including responses to
the specific questions, will be considered by the NRC staff when it
develops the draft regulatory basis. In a separate and related
activity, the NRC staff will be preparing an ANPR concerning the NRC's
design objectives governing dose assessments for radioactive effluents
from light-water-cooled nuclear power reactors, which should be
published for public comment during the public comment period for this
ANPR. The NRC plans to hold a series of public meetings to promote full
understanding of the contemplated action and facilitate public comment.
DATES: Submit comments by November 24, 2014. Comments received after
this date will be considered if it is practical to do so, but the NRC
is only able to ensure consideration of comments received on or before
this date.
[[Page 43285]]
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2009-0279. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: Carol.Gallagher@nrc.gov. For technical questions contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Email comments to: Rulemaking.Comments@nrc.gov. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
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: Cardelia Maupin, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-
2312; email: Cardelia.Maupin@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2009-0279 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 Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2009-0279.
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 Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The
ADAMS accession number for each document referenced (if it is available
in ADAMS) is provided the first time that it is mentioned in the
SUPPLEMENTARY INFORMATION section. 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: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2009-0279 in the subject line of your
comment submission, in order to ensure that the NRC is able to make
your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact
information in comment submissions 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, and 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. Background
The NRC's primary radiation protection regulations are in part 20
of Title 10 of the Code of Federal Regulations (10 CFR). The purpose of
these regulations is to establish standards of protection for both
members of the public and occupational workers from ionizing radiation
resulting from activities conducted under licenses issued by the NRC.
These standards are implemented through the radiation protection
requirements in the 10 CFR part 20 regulations that NRC licensees must
follow. The NRC's predecessor agency, the Atomic Energy Commission
(AEC), initially issued its regulations for radiation protection in the
Federal Register (FR) on January 29, 1957 (22 FR 548). The regulations
substantially followed the recommendations of the first official
publication of the then National Committee on Radiation Protection and
Measurement, which was renamed in 1964 when it was officially charted
by the U.S. Congress (Pub. L. 88-376) and is now known as the National
Council on Radiation Protection and Measurements (NCRP). The NCRP
report was published in 1953 by the Subcommittee on Permissible
Internal Dose, Handbook 52, ``Maximum Permissible Amounts of
Radioisotopes in the Human Body and Maximum Permissible Concentrations
in Air and Water'' (NCRP 1953).\1\ The ICRP essentially adopted the
NCRP 1953 recommendations in ``Recommendations of the International
Commission on Radiological Protection,'' December 1, 1954,'' except for
one major deviation. The ICRP was the first to recommend limiting
radiation doses to persons other than radiation workers, that is, to
members of the public. It recommended a dose one tenth of that
acceptable for occupational workers, which the NCRP later adopted in
1958.\2\
---------------------------------------------------------------------------
\1\ ``A Review of the History of U.S. Radiation Protection
Regulations, Recommendations, and Standards,'' by C.G. Jones, Health
Physics Journal, February 2005, Vol. 88, No. 2, pages 105-126 (ADAMS
Accession No. ML050400427), ``1956 Report on Amendments during 1956
to the 1954 Recommendations of the International Commission on
Radiological Protection,'' 1956, ICRP, and ``Maximum Permissible
Radiation Exposure to Man, A preliminary statement of the National
Committee on Radiation Protection and Measurements,'' 1957.
\2\ ``1954 Recommendations of the International Commission on
Radiological Protection,'' 1955, and ``Permissible Dose: A History
of Radiation Protection in the Twentieth Century,'' by Samuel
Walker, 2000, page 12.
---------------------------------------------------------------------------
Throughout the mid to late 1950s, the ICRP and the NCRP adopted
similar recommendations. For example, in April 1956, the ICRP
considered changes to its dosimetry system that included
recommendations for accumulated internal dose limits for the critical
organs of the human body. The ICRP issued a recommendation of 50 mSv (5
rem) per year for the whole body, gonads, lens of the eye, and active
bone marrow of occupational workers. This recommendation was later
adopted by both the NCRP and the ICRP (NCRP 1957 and ICRP 1958).\3\ The
AEC's 1957
[[Page 43286]]
final rule that promulgated 10 CFR part 20, and the 1960 amendments to
10 CFR part 20 (25 FR 8595, September 7, 1960; and 25 FR 10914,
November 17, 1960), reflect collaborative efforts between the ICRP and
NCRP. Therefore, the dose calculation methodology for the AEC's
radiation protection standards was based, in part, upon the compilation
of the ICRP recommendations developed during the mid to late 1950s and
contained in ICRP Publication 1, ``Recommendations of the International
Commission on Radiological Protection,'' 1959; and ICRP Publication 2,
``Permissible dose for internal radiation,'' 1959.
---------------------------------------------------------------------------
\3\ The recommended ICRP reference format is: ``Recommendations
of the International Commission on Radiological Protection, ICRP
Publication 1 (1959),'' and the condensed reference format used in
this document is: ICRP Publication 1 (1959).
---------------------------------------------------------------------------
Following the establishment of the NRC in 1975, the next and last
revision of 10 CFR part 20 was published in the Federal Register on May
21, 1991 (56 FR 23360). The purpose of the 1991 revision was to adopt
the basic tenets of the ICRP system of radiation dose limitation
described in ICRP Publication 26 (1977), ``Recommendations of the
ICRP.'' \4\ The 1977 recommendations significantly modified previous
radiation protection concepts and principles.
---------------------------------------------------------------------------
\4\ The recommended ICRP reference format is: ``ICRP, 1977.
Recommendations of the ICRP. ICRP Publication 26. Ann. ICRP 1 (3),''
and the condensed reference format used in this document is: ICRP
Publication 26 (1977).
---------------------------------------------------------------------------
It established a new risk-based system of radiation protection
based on three principles: Justification, optimization, and limitation.
(1) Justification requires that no new practice or operation involving
radiation should be allowed unless it produces a net benefit (i.e., no
frivolous use of radiation). (2) Optimization requires all exposures to
be kept as low as is reasonably achievable (ALARA) taking into account
all relevant social and economic factors. (3) Limitation requires that
the effective dose equivalent to individuals shall not exceed the
limits (dose limits) as established for appropriate circumstances. The
ICRP Publication 26 (1977) also provided for the summation of internal
and external exposures for the first time, and eliminated the concept
of a threshold effect or tolerance dose and introduced the concept of
carcinogenesis as a stochastic effect (i.e., health effects that occur
randomly). It provided the foundation and basis for all current Federal
and State regulations, except the U.S. Department of Labor's, which is
still based upon the ICRP recommendations of the 1950s. (Reference: ``A
Review of the History of U.S. Radiation Protection Regulations,
Recommendations, and Standards,'' by C.G. Jones, Health Physics
Journal, February 2005, Vol. 88, No. 2, page 113, (ADAMS Accession No.
ML050400427), and Radiation Protection, Chapter 4, page 4-3, by J.U.
Burnham, et al, 1992)
The majority of the ICRP Publication 26 (1977) recommendations were
adopted in NCRP Report No. 91 (1987), ``Recommendations on Limits for
Exposure to Ionizing Radiation.'' The 1987 report replaced NCRP Report
39 (1971), ``Basic Radiation Protection Criteria,'' and NCRP Report No.
43 (1975), ``Review of the Current Status of Radiation Protection
Philosophy.'' Therefore, the majority of the NCRP Report No. 91 (1987)
recommendations were adopted in the 10 CFR part 20 amendments of 1991.
The NCRP recommendations were issued after the publication of the
proposed 10 CFR part 20 rule; as a result, some of its recommendations
were not adopted in the final rule. For more information about ICRP
Publication 26 (1977) and NCRP Report No. 91 (1987) recommendations
incorporated into 10 CFR part 20 final rule, please see the statement
of considerations for the 1986 proposed 10 CFR part 20 rule (51 FR
1092) and the 1991 final 10 CFR part 20 rule (56 FR 23391).
The 1991 revisions to 10 CFR part 20 were also supported by
information in ICRP Publication 30 (1979-1988), ``Limits for Intakes of
Radionuclides by Workers,'' \5\ including its four parts, four
supplements and index, which were published during the period of 1979
through 1988; and ICRP Publication 32 (1981), ``Limits for Inhalation
of Radon Daughters by Workers.'' These documents were used to calculate
the inhalation values for the annual limits on intake (ALIs) and
derived air concentrations (DACs) for the radionuclides in 10 CFR part
20, appendix B. For more information about the application of these
ICRP publications to the 10 CFR part 20 amendments, please see the
statement of considerations for the 1986 proposed 10 CFR part 20 rule
(51 FR 1092, 1121) and the 1991 final 10 CFR part 20 rule (56 FR
23391).
---------------------------------------------------------------------------
\5\ ICRP Publication 30 was published in four parts and several
supplements. These publications are: ``ICRP, 1979. Limits for
Intakes of Radionuclides by Workers. ICRP Publication 30 (Part 1).
Ann. ICRP 2 (3-4);'' ``ICRP, 1979. Limits for Intakes of
Radionuclides by Workers. ICRP Publication 30 (Supplement to Part
1). Ann. ICRP 3 (1-4);'' ``ICRP, 1980. Limits for Intakes of
Radionuclides by Workers. ICRP Publication 30 (Part 2). Ann. ICRP 4
(3-4);'' ``ICRP, 1981. Limits for Intakes of Radionuclides by
Workers. ICRP Publication 30 (Part 3). Ann. ICRP 6 (2-3);'' ``ICRP,
1982. Limits for Intakes of Radionuclides by Workers. ICRP
Publication 30 (Supplement B to Part 3). Ann. ICRP 8 (1-3);''
``ICRP, 1982. Limits for Intakes of Radionuclides by Workers. ICRP
Publication 30 (Index). Ann. ICRP 8 (4);'' and ``ICRP, 1988. Limits
for Intakes of Radionuclides by Workers: An Addendum. ICRP
Publication 30 (Part 4). Ann. ICRP 19 (4).'' These publications are
referenced collectively in the condensed reference formats as ICRP
Publication 30 (1979-1988).
---------------------------------------------------------------------------
In ICRP Publication 45 (1985),\6\ ICRP issued a statement
recommending that the annual dose limit for members of the general
public be reduced from 5 mSv (500 mrem) to 1 mSv (100 mrem); this
annual dose limit which was adopted in the NRC's 1991 rulemaking.\7\ In
addition, when the 10 CFR part 20 rulemaking was near completion, the
ICRP developed a new series of recommendations as ICRP Publication 60
(1991).\8\
---------------------------------------------------------------------------
\6\ The recommended ICRP reference format is: ICRP, 1985.
Developing a Unified Index of Harm. ICRP Publication 45. Ann. ICRP
15 (3), and the condensed reference format used in this document is:
ICRP Publication 45 (1985).
\7\ International Commission on Radiological Protection,
``Statement from the 1985 Paris Meeting of the ICRP,'' British
Journal of Radiology, Vol. 58, page 910:1985: also; Health Physics,
45(6), pages 828-829 (June 1985).
\8\ The ICRP recommended format is: ICRP, 1991. 1990
Recommendations of the International Commission on Radiological
Protection. ICRP Publication 60. Ann. ICRP 21 (1-3), and the
condensed reference format used in this ANPR is: ICRP Publication 60
(1991).
---------------------------------------------------------------------------
The ICRP Publication 60 (1991) recommendations included lowering
the occupational dose \9\ limit from 50 mSv (5 rem) per year to a 5-
year average of 20 mSv (2 rem) per year, with the dose in any given
year not to exceed 50 mSv (5 rem); eliminating dose limits for
individual organs, except for the skin and the lens of the eye;
lowering the exposure limits to an embryo/fetus during the gestation
period from 5 mSv (500 mrem) to 4.5 mSv (450 mrem); and changing
radiation protection terminology and definitions. The ICRP Publication
60 (1991) recommendations were not considered in the NRC's 1991
rulemaking because they were issued after the rule's public comment
period ended. Following the issuance of ICRP Publication 60 (1991), the
ICRP issued a series of publications that revised internal dosimetry
models. The revised internal dosimetry models superseded many, but not
all, of the models described in ICRP Publication 30 (1979-1988) and
earlier ICRP publications. As
[[Page 43287]]
a result, there are differences between 10 CFR part 20 and the
dosimetry approaches and occupational dose limits reflected in ICRP
Publications 60-61, 66-69, 71-72, and 74.\10\
---------------------------------------------------------------------------
\9\ The NRC's regulations define ``occupational dose'' as ``the
dose received by an individual in the course of employment in which
the individual's assigned duties involve exposure to radiation or to
radioactive material from licensed and unlicensed sources of
radiation, whether in the possession of the licensee or other
person. Occupational dose does not include doses received from
background radiation, from any medical administration the individual
has received, from exposure to individuals administered radioactive
material and released under Sec. 35.75, from voluntary
participation in medical research programs, or as a member of the
public.'' 10 CFR 20.1003 (definition of ``occupational dose'').
\10\ ICRP Publication 61 (1991), ``Annual Limits on Intake of
Radionuclides by Workers Based on the 1990 Recommendations;'' ICRP
Publication 66 (1994), ``Human Respiratory Tract Model for
Radiological Protection;'' ICRP Publication 67(1993), ``Age-
dependent Doses to Members of the Public from Intake of
Radionuclides--Part 2 Ingestion Dose Coefficients;'' ICRP
Publication 68 (1994), ``Dose Coefficients for Intakes of
Radionuclides by Workers;'' ICRP Publication 69 (1995), ``Age-
dependent Doses to Members of the Public from Intake of
Radionuclides--Part 3 Ingestion Dose Coefficients;'' ICRP
Publication 71 (1995), ``Age-dependent Doses to Members of the
Public from Intake of Radionuclides--Part 4 Inhalation Dose
Coefficients;'' ICRP Publication 72 (1995), ``Age-dependent Doses to
the Members of the Public from Intake of Radionuclides--Part 5
Compilation of Ingestion and Inhalation Coefficients;'' and ICRP
Publication 74 (1996), ``Conversion Coefficients for use in
Radiological Protection against External Radiation.''
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Other than conforming changes to update cross-references to 10 CFR
part 20 found in other NRC regulations, the 1991 rulemaking did not
substantively revise other NRC regulations (e.g., 10 CFR parts 32, 50,
51, 61, and 72) that had explicit dose criteria. Consequently, some NRC
regulations are still based on ICRP Publication 1 (1959), ICRP
Publication 2 (1959), and NCRP reports of the 1950s. The differences
between the 10 CFR part 20 requirements and the ICRP recommendations
issued after ICRP Publication 30 (1979-1988) have created challenges
for the NRC and its licensees.
The NRC staff described these challenges in its paper to the
Commission, 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,'' dated August 2, 2001 (ADAMS
Accession No. ML011580363). Specifically, the challenges included
licensee requests to use dosimetry methods based upon the
recommendations in the various ICRP publications issued after ICRP
Publication 30 (1979-1988) for both external (to the body) and internal
(within the body) dose assessments; licensees exceeding, or potentially
exceeding, dose limits, although the NRC staff had determined that in
some cases the 10 CFR part 20 methods for assessing internal and
external dose were overly conservative relative to the most current
ICRP recommendations; the general areas of differences between
radiation protection requirements of the NRC and those nations that
relied upon the later ICRP recommendations, including the differences
in occupational exposure limits; and the use by some Federal agencies
(e.g., U.S. Department of Energy (DOE) and the U.S. Environmental
Protection Agency (EPA)) of dosimetry models based upon ICRP
recommendations that were either not incorporated in the 1991
rulemaking or were published after that rulemaking.
The SECY-01-0148 paper also discussed options for amending 10 CFR
part 20 by adopting the ICRP's recommended occupational dose limits,
dosimetric models, and related parameters, and the advantages and
disadvantages of the NRC's adoption of the recommendations in ICRP
Publication 60 (1991) and the dosimetry models in ICRP Publications 66-
69, 71-72, and 74. The paper concluded with an NRC staff recommendation
not to amend 10 CFR part 20 at that time, but rather to initiate an
effort to study the impacts of adopting the recommended ICRP dosimetry
models by through outreach with stakeholders; working with other
Federal agencies through the Interagency Steering Committee on
Radiation Standards (ISCORS) to ensure a coherent approach within the
United States in radiation protection standards and dosimetric models;
developing a technical information basis to provide a better
understanding of analytical impacts of possible alternative changes to
10 CFR part 20; and monitoring the work of the ICRP as it develops its
revision to implement the ICRP Publication 60 (1991) recommendations.
In the staff requirements memorandum (SRM) to SECY-01-0148, dated
April 12, 2002, (ADAMS Accession No. ML021050104), the Commission
approved the NRC staff's recommendations to continue to work with and
monitor the efforts of other Federal agencies to ensure a coherent
approach to U.S. radiation protection standards and dosimetric models
and to continue to monitor work of the ICRP. The Commission disapproved
the development of a communication plan and a technical information
basis. The Commission also directed the NRC staff to continue to
consider and grant, as appropriate, licensee requests to use the ICRP
Publication 60 (1991) revised internal dosimetry models on a case-by-
case basis. As a result, the current NRC regulatory framework is a
mixture of radiological standards, concepts and quantities, ranging
from the 1959 recommendations in ICRP Publication 1 (1959) to the
modeling and numeric values of the 1990 recommendations in ICRP
Publication 60 (1991).\11\
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\11\ The NRC's current 10 CFR part 20 regulations do not
expressly incorporate the recommendations of ICRP Publication 60
(1991) but are based upon the recommendations of ICRP Publications
26 and 30. The NRC's licensees must request use of the ICRP
Publication 60 (1991) internal dosimetry models. If approved by the
NRC, such a request is treated as an exemption from 10 CFR part 20
regulations. The NRC's authority to grant exemptions is in 10 CFR
20.2301. As a matter of practice, in such exemption approvals, the
NRC only authorizes the use of the dosimetric concepts and
quantities in the ICRP Publication 60 (1991) recommendations.
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With the issuance of ICRP Publication 103 (2007),\12\ the NRC was
again presented with the question of whether to update its regulations
to reflect the ICRP's recommendations in the area of radiation
protection science. This question was addressed in SECY-08-0197,
``Options to Revise Radiation Protection Regulations and Guidance with
Respect to the 2007 Recommendations of the ICRP,'' dated December 18,
2008 (ADAMS Accession No. ML091310193). This paper described and
evaluated the ICRP Publication 103 (2007) recommendations along with an
NRC staff's recommendation that the Commission approve a closer
alignment of the NRC's regulatory framework with the ICRP Publication
103 (2007) recommendations. The NRC staff's recommendation set forth
some steps to achieve this alignment, including the development of a
technical basis, or the rationale, for a proposed rulemaking to amend
the NRC's radiation protection regulations and outreach with
stakeholders and interested parties to identify issues, options, and
impact information. The NRC staff stated that it would provide the
Commission with the results of the stakeholder and interested party
interactions, the scope of the proposed rulemaking, including policy
and implementation issues, the resources needed for the rulemaking, and
the projected rulemaking completion date, which would be dependent on
the ICRP's development of essential technical information.
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\12\ The recommended ICRP reference format is ``ICRP, 2007. The
2007 Recommendations of the International Commission on Radiological
Protection. ICRP Publication 103. Ann. ICRP 37 (2-4), 2007.'' The
condensed ICRP reference format used throughout this document is:
``ICRP Publication 103 (2007).''
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The SECY-08-0197 paper noted that the ICRP Publication 103 (2007)
recommendations provided new values for the tissue weighting
factors.\13\ The paper also noted that ICRP estimated the following
dates and deliverables for updated scientific information and
[[Page 43288]]
guidance for its new dosimetry system: a. A dose conversion factors for
calculating occupational exposure from the most commonly used
radioisotopes by 2011, b. dose conversion factors for calculating dose
limits for members of the public by 2012, and c. dose conversion
factors for calculating exposure for all radionuclides by 2014. At
present, this information is still being developed. The ICRP's
development of biokinetic and dosimetric models and dose coefficients
for both worker and public exposure to radionuclides based on the ICRP
recommendations was projected for completion by 2014. It is anticipated
that this information will not be available until after 2015.
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\13\ Weighting factor WT, for an organ or tissue (T)
is the proportion of the risk of stochastic effects (i.e., health
effects that occur randomly) resulting from irradiation of that
organ or tissue to the total risk of stochastic effects when the
whole body is irradiated uniformly (10 CFR 20.1003, definition of
``Weighting factor WT'').
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As pointed out in SECY-08-0197, the revised dose conversion factors
are crucial to any amendment of the NRC's radiation protection
framework. These factors could provide the basis for revising the
numeric values of weighting factors, ALIs, and DACs contained in the
following 10 CFR part 20 requirements: 10 CFR part 20, appendix B,
Table 1, ``Occupational Values;'' 10 CFR part 20, appendix B, Table 2,
``Effluent Concentrations;'' and 10 CFR part 20, appendix B, Table 3,
``Releases to Sewers.''
In the SRM to SECY-08-0197, ``Options to Revise Radiation
Protection Regulations and Guidance with Respect to the 2007
Recommendations of the International Commission on Radiological
Protection,'' dated April 2, 2009 (ADAMS Accession No. ML090920103),
the Commission approved the NRC staff's recommended option to 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 ICRP
Publication 103 (2007) recommendations. The Commission also directed
the NRC staff to continue to participate in national and international
forums on radiation protection and to keep them informed of the results
of these outreach activities. Notably, the Commission agreed with both
the NRC staff and the NRC's Advisory Committee on Reactor Safeguards
(ACRS) that ``the current NRC regulatory framework continues to provide
adequate protection of the health and safety of workers, the public,
and the environment.'' \14\ In this regard, the Commission stated that
from ``a safety regulation perspective, ICRP Publication 103 (2007)
proposes measures that go beyond what is needed to provide for adequate
protection.'' \15\ During the outreach activities associated with the
potential alignment with the ICRP Publication 103 (2007)
recommendations, the Commission directed the NRC staff to ``focus the
discussion on discerning the benefits and burdens associated with
revising the radiation protection regulatory framework.'' \16\
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\14\ SRM-SECY-08-0197, ``Options to Revise Radiation Protection
Regulations and Guidance with Respect to the 2007 Recommendations of
the International Commission on Radiological Protection,'' dated
April 2, 2009 (ADAMS Accession No. ML090920103), at 1.
\15\ Id.
\16\ Id.
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The Commission also directed the NRC staff to examine how a lower
occupational dose limit of 20 mSv (2 rem) per year has affected the
medical and industrial sectors in countries that have implemented the
ICRP recommendation when developing the technical basis for the
rulemaking. Finally, based on the extent and complexity of the
stakeholder comments received, the Commission directed the NRC staff to
either (1) provide the Commission with a proposed rule once the
technical basis has been developed, or (2) provide a paper to the
Commission outlining any substantive policy issues and options for
their resolution prior to developing a proposed rule.
In response to the Commission's direction in SRM-SECY-08-0197, NRC
staff conducted stakeholder outreach activities on issues about
potential changes to the NRC's radiation protection regulations. Three
Federal Register notices were issued requesting public feedback and
comments (74 FR 32198, July 7, 2009; 75 FR 59160, September 27, 2010;
and 76 FR 53847, August 30, 2011). Presentations and discussions were
made at a variety of professional societies, licensee organizations,
public interest groups, and State organizations (e.g., Conference of
Radiation Control Program Directors and the Organization of Agreement
States).
In the fall of 2010, the NRC staff conducted a series of
facilitated round table workshops in Washington, DC, Los Angeles, CA,
and Houston, TX. Each workshop included representatives from a broad
range of users of radioactive material; this process provided an
opportunity for various groups of stakeholders to have a focused
discussion of the technical issues associated with potential changes to
the NRC's radiation protection standards. The October 2010 workshop in
Washington, DC focused on the nuclear power and fuel cycle industries
and the radiation protection programs of other Federal agencies (e.g.,
EPA, DOE, U.S. Navy, Armed Forces Radiobiology Research Institute, and
National Institutes of Health). The November 2010 Los Angeles workshop
focused on medical uses of radiation, and the November 2010 Houston, TX
workshop focused on industrial radiography. These workshops provided
stakeholders the opportunity to discuss the various technical issues
with each other and with NRC staff. Transcripts of each workshop and
written comments received in response to the Federal Register notices
are publicly available through the NRC's public Web site on the page
entitled, ``Options to Revise Radiation Protection Regulations and
Guidance,'' https://www.nrc.gov/about-nrc/regulatory/rulemaking/potential-rulemaking/opt-revise.html.
In addition, the NRC staff's outreach activities included
participation in the revision of the International Basic Safety
Standards by the International Atomic Energy Agency (IAEA) from 2009
through its completion in the second quarter of 2013, and observation
of the revision of the Euratom Basic Safety Standards Directive in the
European Union. Both the IAEA's and Euratom's revisions focused on
aligning their requirements with the ICRP Publication 103 (2007)
recommendations.
After extensive stakeholder engagement, the NRC staff determined
that an additional paper to the Commission outlining substantive policy
issues was needed. This additional policy paper was provided as SECY-
12-0064, ``Recommendations for Policy and Technical Direction to Revise
Radiation Protection Regulations and Guidance,'' dated April 25, 2012
(ADAMS Accession No. ML121020108). The SECY-12-0064 paper summarized
the NRC staff's interactions with stakeholders as directed by SRM-SECY-
08-0197, and provided policy and technical guidance on potential
revisions to the NRC's radiation protection regulations.
In SECY-12-0064, the NRC staff recommended that the NRC's
regulatory framework be amended to reflect the new terminology and dose
calculation methodologies to align with national and international
scientific approaches for estimating radiation exposure and risk
contained in ICRP Publication 103 (2007). The NRC staff, however,
recommended that the NRC not initiate a rulemaking to reflect these
changes until the ICRP published its updated dose coefficients and
other supporting information, so that a single comprehensive change
could be made to the relevant provisions and appendices
[[Page 43289]]
of 10 CFR part 20. The NRC staff also recommended that the following be
explored in greater detail: a reduction in the occupational dose limit
to 20 mSv (2 rem) per year, including the mechanisms that would be
available to provide some flexibility for licensees to request a higher
limit under specified conditions; the impacts of a reduction in the
dose limit for the lens of the eye to either 50 mSv (5 rem) or 20 mSv
(2 rem), including how the prevention of cataracts should be viewed in
comparison with the potential formation of cancer or other adverse
impacts; and the impacts of a change in the dose limit for the embryo/
fetus to 1 mSv (100 mrem).
Finally, in SECY-12-0064, the NRC staff recommended that: No
additional ALARA (as low as is reasonably achievable) planning
requirements should be made, however applicable regulatory guidance
should be updated to provide additional examples of mechanisms
acceptable in the development and implementation of radiation
protection programs; the NRC staff should continue to monitor and
interact with various international organizations in developing tools
and methodologies for assessment of doses in the environment; the NRC
staff should explore the implications, benefits, and costs of aligning
NRC regulations in 10 CFR part 20 to the NRC metrication policy; and
the NRC staff should explore a more detailed examination of the
implications, benefits, and costs of requiring additional NRC license
categories and Agreement State \17\ licensees to report occupational
exposures to the NRC's Radiation Exposure Information and Reporting
System (REIRS) database.
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\17\ Section 274 of the Atomic Energy Act of 1954, as amended
(AEA), authorizes the NRC to relinquish specified authority
concerning the regulation of certain radioactive materials to a
State, which then assumes regulatory authority over those
radioactive materials following the signing of a written agreement
between the NRC and the State. Becoming an Agreement State is at the
discretion of the State; at present 37 states have Agreement State
status. Prior to such relinquishment, the NRC must determine whether
the proposed State regulatory program is adequate to protect public
health and safety and is compatible with NRC's regulations before it
can become an Agreement State. Once Agreement State status is
established, the NRC will monitor the Agreement State program.
Amendments to NRC regulations may require corresponding changes to
the regulations of the various Agreement States. The NRC's Agreement
State regulations are in 10 CFR part 150. The definitions section of
10 CFR part 150, 10 CFR 150.3, defines the term ``Agreement State''
as ``any State with which the [NRC] or the Atomic Energy Commission
has entered into an effective agreement under subsection 274b of the
[AEA].''
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In SRM-SECY-12-0064, ``Recommendations for Policy and Technical
Direction to Revise Radiation Protection Regulations and Guidance,''
dated December 17, 2012 (ADAMS Accession No. ML12352A133), the
Commission approved in part and disapproved in part the NRC staff's
recommendations. Specifically, the Commission approved the NRC staff's
development of a draft regulatory basis for a revision to 10 CFR part
20 to align with the most recent methodology and terminology for dose
assessment in ICRP Publication 103 (2007), including consideration of
any conforming changes to all NRC regulations. The Commission directed
the NRC staff to develop improvements in the NRC's guidance for those
segments of the regulated community that would benefit from more
effective implementation of the ALARA strategies and programs to comply
with regulatory requirements. The Commission also directed the NRC
staff to continue discussions with stakeholders regarding dose limits
for the lens of the eye and the embryo/fetus. In addition, the
Commission directed the NRC staff to continue discussions with
stakeholders on alternative approaches to deal with individual
protection at or near the current dose limit. Finally, the Commission
directed the NRC staff to improve reporting of occupational exposure by
the NRC and Agreement State licensees to the NRC's REIRS database.
In SRM-SECY-12-0064, the Commission disapproved the NRC staff's
recommendations to develop a draft regulatory basis to reduce the
occupational total effective dose equivalent to 20 mSv (2 rem) per
year. The Commission also disapproved the elimination of traditional or
``English'' dose units to measure radiation exposure from the NRC's
regulations. Rather, the Commission directed the continuation of the
use of both traditional and International System (SI) \18\ units in the
NRC's regulations.
---------------------------------------------------------------------------
\18\ ``SI'' is the French acronym for ``Le Syst[egrave]me
international d'unit[eacute]s'' the modern form of the metric
system.
---------------------------------------------------------------------------
In a separate and related activity, the NRC staff will be preparing
an ANPR for 10 CFR part 50, appendix I (RIN 3150-AJ38; NRC-2014-0044),
which concerns the NRC's design objectives governing dose assessments
for radioactive effluents from light-water-cooled nuclear power
reactors. The preparation of the 10 CFR part 50, appendix I, ANPR is
also in response to the Commission's direction in SRM-SECY-12-0064,
which stated that the NRC staff shall, along with the development of
the draft regulatory basis for the 10 CFR part 20 regulations, engage
in a parallel effort to develop a draft regulatory basis for aligning
the 10 CFR part 50, appendix I, design objectives with the most recent
methodology and terminology for dose assessment.\19\
---------------------------------------------------------------------------
\19\ The NRC staff has not yet determined whether it will
prepare one draft regulatory basis, covering both potential
revisions to the 10 CFR part 20 regulations and the 10 CFR part 50,
appendix I, design objectives, or two separate bases.
---------------------------------------------------------------------------
III. Regulatory Objectives
In accordance with the Commission's direction provided in SRM-SECY-
12-0064, the NRC staff is preparing a draft regulatory basis to support
a possible amendment to 10 CFR part 20, and with conforming changes to
other NRC regulations to align more closely with the ICRP Publication
103 (2007) dose assessment methodology and terminology. The NRC staff
is continuing to hold discussions with stakeholders regarding
alternative approaches to ensure individual protection at or near the
current dose limit are examined, including considerations of whether
revised or additional regulatory requirements and guidance may be
appropriate to ensure that cumulative occupational exposures \20\ are
minimized, and whether progressive restrictions should be taken as
cumulative exposures increase; whether the dose limits for the lens of
the eye should be reduced; whether the dose limits to the embryo/fetus
of a declared pregnant occupational worker should be reduced; and
whether any undue hardships arise as a result of applying the NRC's
metrication policy to any amendment of the 10 CFR part 20 regulations.
The results of these discussions with stakeholders will be reflected in
the draft regulatory basis. Finally, the 10 CFR part 20 draft
regulatory basis will consider improvements in the reporting of
occupational exposure by the NRC and Agreement State licensees,
including those licensees who currently do not currently submit reports
to the NRC's REIRS database.
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\20\ The total dose that an occupationally exposed worker
receives as a result of repeated exposures to ionizing radiation to
the same portion of the body, or to the whole body, over time
(https://www.nrc.gov/reading-rm/basic-ref/glossary/cumulative-dose.html).
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IV. Specific Considerations
The NRC staff has identified policy and technical issues to guide
the development of a draft regulatory basis for the potential revisions
to the NRC's radiation protection regulations and guidance as described
in Section III of this ANPR. Sections A through F that follow provide a
summary of these policy and technical issues. A more detailed
discussion of each issue is
[[Page 43290]]
contained in a series of six issue papers prepared by NRC staff and
identified in Section VIII of this ANPR.
A. Update 10 CFR Part 20 To Align With ICRP Publication 103 Methodology
and Terminology
Several revisions are under consideration to more closely align the
existing NRC regulations in 10 CFR part 20 with the ICRP Publication
103 (2007) methodology and terminology for dose assessment. During the
30-year period of 1977 to 2007, the ICRP published three key
radiological protection recommendations, ICRP Publication 26 (1977),
ICRP Publication 60 (1991), and ICRP Publication 103 (2007). The
current NRC regulatory framework is a mixture of radiological
standards, concepts and quantities ranging from the recommendations in
ICRP Publication 1 (1959) to the modeling and numeric values of the
recommendations in ICRP Publication 60 (1991).
The current 10 CFR part 20 regulations are based primarily upon the
recommendations of ICRP Publication 26 (1977); however, there is one
difference in terminology worth noting. The ICRP recommendations used
the phrases ``the sum of the dose-equivalent from external exposure''
and ``the committed effective dose equivalent from the intake of
radionuclides.'' The NRC's regulations use the term ``total effective
dose equivalent'' (TEDE) to represent the summation of dose received
from sources external to the body and dose received from the intake of
radioactive materials.
In 1991, the ICRP revised its recommendations for dose calculation.
The ICRP Publication 60 (1991) recommendations provided changes in the
way tissue and radiation weighting factors were defined and used
(moving from quality factors to radiation weighting factors). A
corresponding change in terminology was also made. For example, ICRP
Publication 60 (1991) introduced the term ``effective dose,'' which was
defined as the sum of the weighted equivalent doses in all the tissues
and organs of the body.
Additionally, the ICRP Publication 103 (2007) recommendations made
revisions to the calculation of dose, including (1) modification of the
modeling used for calculation of radiation exposures, (2) changes in
values of tissue weighting factors and radiation weighting factors, and
(3) substantial modifications of the metabolic models used to represent
the movement of radioactive material through the human body. The human
body can now be modeled as a more complex set of mathematical and
``voxel'' \21\ phantoms as a result of advances in medical imaging
technology since the last substantial amendment of the 10 CFR part 20
regulations in 1991. These technological advances have resulted in the
development of reference computational phantoms that are specific
models for adult males and females, 15-year-old males and females, and
for various other age groups, including infants, 1-year-old, 5-year-
old, and 10-year-old children. The reference phantoms for the human
body are described in general terms in ICRP Publication 103 (2007) and
in ICRP Publication 110 (2009).\22\
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\21\ Voxel is the shortened term for volume pixel, the smallest
distinguishable box-shaped part of a three-dimensional image. Voxel
images are primarily used in the field of medicine and are developed
from x-rays, CAT (Computed Axial Tomography) scans, and MRIs
(Magnetic Resonance Imaging) allowing medical professionals to
obtain accurate 3D models of the human body. (Reference: Webopedia
(www.webopedia.com)).
\22\ The ICRP recommended format is: ICRP, 2009. Adult Reference
Computational Phantoms. ICRP Publication 110. Ann. ICRP 39 (2), and
the condensed format used in this document is: ICRP Publication 110
(2009).
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The availability of models for different age groups provides the
opportunity to calculate the numeric values for public exposure to
effluents in a more comprehensive manner as compared to the previous
calculation methodology of basing assessments primarily on an adult
member of the public. A general population includes individuals of both
genders and various age groups that range from newborns to senior
citizens. Over time, an individual matures from infancy to adulthood,
which includes various stages of development. Therefore, the scientific
community is evaluating the appropriate approach for a member of the
public that would account for the period of time spent at different
ages so that the long-term risk of exposure to radiological effluents
over a number of years can be properly represented. In particular, the
ICRP is considering the use of an age and gender weighted dose
coefficient for developing a set of values for environmental intake of
radionuclides. Similarly, the NRC is also considering revising the
definition of the reference person \23\ for its use in environmental
dose calculations. The NRC is considering the use of the age and gender
averaged approach to provide a more realistic representation of a
member of the public that explicitly considers the presence of infants
and children within the population.
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\23\ The NRC's regulations use the term ``reference man,'' which
means a hypothetical aggregation of human physical and physiological
characteristics arrived at by international consensus. These
characteristics may be used by researchers and public health workers
to standardize results of experiments and to relate biological
insult to a common base (10 CFR 20.1003, definition of ``reference
man'').
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The concept of a reference person may be like the approach
documented in the DOE Technical Standard, DOE-STD-1196-2011, ``Derived
Concentration Technical Standard,'' dated April 2011 (ADAMS Accession
No. ML13323B598). The DOE-STD-1196-2011 calculates derived
concentration standards using age-specific effective dose coefficients
for reference members of the public, along with age and gender
dependent intake rates for ingestion of water and inhalation of air.
The members of the public are represented by six age subgroups
(newborns,\24\ 1-year-old, 5-year-old, 10-year-old, and 15-year-old
children and adults). The analysis weights the effective dose
coefficients for each subgroup by their fractional representation in
the U.S. population and by their intake of the radionuclide through
inhalation, ingestion, or air submersion over their lifetimes. The DOE
standard is based on the weighting factors and dose coefficients in
ICRP Publication 60 (1991).
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\24\ The DOE standard uses the term ``newborn,'' while ICRP
Publication 103 (2007) uses the term ``infant.''
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As part of its development of the draft regulatory basis, the NRC
staff will consider revising the regulations in 10 CFR part 20, as well
as making conforming changes to other NRC regulations, to incorporate
the ICRP term, ``effective dose.'' The NRC staff recognizes the
preference, from a regulatory stability standpoint, for retaining the
term ``total effective dose equivalent,'' but will analyze, in the
draft regulatory basis, the advantages and disadvantages of replacing
``total effective dose equivalent'' with ``effective dose'' or ``total
effective dose'' in its regulations.
The same terminology as it is used elsewhere in the world may
present qualitative benefits of consistency and ease in communication.
With regard to the ICRP's dose assessment methodology recommendations,
the NRC staff will consider, in the draft regulatory basis, replacing
the definition of ``weighting factor'' (WT) in 10 CFR
20.1003 with the tissue weighting factors in Table 3, ICRP Publication
103 (2007), and replacing the quality factors in 10 CFR 20.1004, Tables
(B).1 and (B).2, ``Units of Radiation Dose,'' with the radiation
weighting factors in Table 2, ICRP Publication 103 (2007), along with
other associated changes (e.g., replacing ``dose equivalent'' with the
[[Page 43291]]
term ``equivalent dose,'' and replacing ``effective dose equivalent''
with the term ``effective dose,'' and revising the definition of the
term ``quality factor''). If approved by the Commission, an update of
10 CFR part 20 to reflect the tissue weighting factors and radiation
weighting factors from ICRP Publication 103 (2007) would amend these
sections.
In addition, as a part of the development of the draft regulatory
basis, NRC staff will consider revising the values in appendix B to 10
CFR part 20, ``Annual Limits on Intake (ALIs) and Derived Air
Concentrations (DACs) of Radionuclides for Occupational Exposure;
Effluent Concentrations; Concentrations for Release to Sewerage;''
Table 1, ``Occupational Values;'' Table 2, ``Effluent Concentrations;''
and Table 3, ``Releases to Sewers,'' with new values for ALIs, DACs,
effluent concentrations, and sewer concentrations. The current values
in appendix B are based on a public dose limit of 0.5 mSv (50 mrem).
The various types of NRC licenses pose different challenges for the
use of methodology and terminology for dose assessment. In some
instances, exposures to occupational workers and members of the public
at a licensed facility are only from sources external to the body.
Conversely, other types of licensed facilities have the potential for
significant exposures to occupational workers and members of the public
due to intake of radionuclides. These types of licenses would be more
directly impacted by the revision of the WT, ALI, and DAC
values. Therefore, the NRC staff is seeking to understand how various
proposals for addressing this issue would affect licensee activities.
Likewise, the NRC staff wishes to understand the possible impacts of
the proposals, and more specifically, the reasons why certain proposals
may be difficult to achieve or may undermine radiation protection.
Therefore, the NRC staff is seeking to understand the impacts of
adopting the ICRP Publication 103 (2007) methodology and terminology
into its regulatory program.
The Issue Paper 1, ``Update 10 CFR Part 20 to Align with
International Commission on Radiological Protection Publication 103
Methodology and Terminology,'' ICRP Publication 103, provides a more
detailed discussion and is available in ADAMS under Accession No.
ML14084A342. In addition, the following questions are intended to
elicit information from the public, the regulated community, and other
stakeholders.
Questions
Q1-1: What are the implications of changing the NRC's regulations
to specify ``total effective dose'' in place of the current term
``total effective dose equivalent?'' To the extent possible, please
provide specific implementation and operational cost information on the
impacts of this change relative to licensee procedures, training,
recordkeeping, and reporting. This information is necessary for the NRC
to determine whether the imposition of such requirements on NRC
licensees is justified.
Q1-2: If the NRC adopts the dose assessment terminology and
methodology of ICRP Publication 103 (2007) in a future rulemaking, what
time period should the NRC consider providing for implementation of the
ICRP Publication 103 (2007) methodology and terminology?
Q1-3: How should the calculations of effluent concentration,
currently in the 10 CFR part 20 radiation protection regulations, be
modified to reflect advances in modeling that are now available? In
particular, the NRC is interested in preliminary views on the age and
gender averaged approach.
Q1-4: Should the public dose limit of 0.5 mSv (50 mrem) continue to
be the basis for the effluent concentration limits for the
radionuclides in 10 CFR part 20, appendix B, Table 2, Columns 1 and 2?
Should it be reduced or otherwise modified?
B. Occupational Dose Limit for the Lens of the Eye
The ICRP Publication 26 (1977) provided an occupational dose limit
of 300 mSv (30 rem) per year for the lens of the eye. During the
1980's, it became clear from epidemiological studies that the risks
from radiation exposure were higher than those anticipated when the
ICRP Publication 26 (1977) recommendations were published. As a result,
in ICRP Publication 60 (1991), the ICRP recommended reducing the
occupational dose limit for the lens of the eye to 150 mSv (15 rem) per
year, which is 50 percent of the previously recommended limit of 300
mSv (30 rem) per year in ICRP Publication 26 (1977). In its 1991
rulemaking for 10 CFR part 20, the NRC adopted the ICRP Publication 60
(1991) recommendation in 10 CFR 20.1201(a)(2)(i). In addition, the 1991
amendments added a definition of ``lens dose equivalent'' (LDE), which
is the external exposure of the lens of the eye at a tissue depth of
0.3 cm (300 mg/cm\2\).\25\
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\25\ 10 CFR 20.1003, definition of ``Lens dose equivalent
(LDE).''
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As the ICRP continued to re-examine its radiation protection
principles, it noted that the eye is one of the most sensitive organs
of the body, that the protection of the eye against the effects of
ionizing radiation is designed primarily to prevent the formation of
cataracts, and that the most sensitive part of the eye for cataract
formation is the lens. Cataract formation falls under the class of
radiation effects referred to as deterministic (or tissue reactions as
used in ICRP Publication 103 (2007)). At doses above a certain
threshold, the severity of cataract formation increases with dose, but
the radiation-induced incidence of cataract formation below the
threshold dose is believed to be essentially zero.
On April 21, 2011, the ICRP issued a statement on tissue reactions
indicating that a review of recent epidemiological evidence suggests
that there are some tissue reaction effects, particularly those with
very late manifestation, where threshold doses are, or might be, lower
than previously considered. For the lens of the eye, the threshold
absorbed dose is now considered to be 0.50 Gy (50 rad). The ICRP's
statement was based on draft report, ``Early and Late Effects of
Radiation in Normal Tissues and Organs: Threshold Doses for Tissue
Reactions and Other Non-Cancer Effects of Radiation in a Radiation
Protection Context,'' which was published on January 20, 2011, by ICRP.
The draft report contained information reviewing the early and late
effects of radiation in 36 normal tissues and organs with respect to
radiation protection. It also provided new estimates of threshold doses
for tissue injury in all organ systems, and for morbidity and
mortality, following acute, fractionated, or chronic exposure.
On, August 30, 2011, the NRC solicited public comments on the
proposed new ICRP recommendations with the publication, ``New
International Commission on Radiological Protection Recommendations on
the Annual Dose Limit to the Lens of the Eye,'' in the Federal Register
(76 FR 53847). A summary of stakeholder views on this issue is provided
in SECY-12-0064, Enclosure 3, ``Assessment of Technical Issues and
Feedback,'' pages 13 through 17 (ADAMS Accession No. ML121020108).
The ICRP revised the January 2011 draft report based on the
comments received during the comment period. Its findings were included
in ICRP Publication 118 (2012), ``ICRP Statement on Tissue Reactions
and Early and Late Effects of Radiation in Normal Tissues and Organs--
Threshold Doses for
[[Page 43292]]
Tissue Reactions in a Radiation Protection Context,'' published on
August 28, 2012. The ICRP Publication 118 (2012) formalized the new
ICRP recommendations for the lens of the eye that are based on the
prevention of radiogenic cataracts. For planned occupational exposure
situations, the ICRP recommended reducing the limit on equivalent dose
for the lens of the eye to 20 mSv (2 rem) per year, averaged over 5
consecutive years (i.e., 100 mSv (10 rem) in 5 years), with no single
year exceeding 50 mSv (5 rem), which is significantly lower than ICRP's
previous recommendation of 150 mSv (15 rem) per year in ICRP
Publication 60 (1991).
The NRC believes that it is appropriate, and scientifically
justified, to explore in greater detail the impact of a reduction in
the dose limit for the lens of the eye to 50 mSv (5 rem). The NRC also
believes that further discussion is warranted on how the prevention of
cataracts (which can be corrected by a well-established surgical
procedure) compares to efforts to reduce the probability of cancer, a
disease posing a far greater health risk. The approaches to be
considered include adopting the recommendations in ICRP Publication 118
(2012), moving towards closer alignment with the ICRP recommendations,
or retaining the current dose limit. Any new requirements will have
implications for measuring occupational exposures and the need to
better estimate the dose to the lens of the eye.
The Issue Paper 2, ``Occupational Dose Limit for the Lens of the
Eye,'' provides a more detailed discussion and is available in ADAMS
under Accession No. ML14084A341. In addition, the following questions
are intended to elicit information from the public, the regulated
community, and other stakeholders to obtain this information.
Questions
Q2-1: Is closer alignment with or adoption of the ICRP Publication
118 (2012) recommendations regarding the dose limits to the lens of the
eye appropriate given the scientific information now available?
Q2-2: How should the impact of a radiation-induced cataract be
viewed in comparison with other potential radiation effects?
Q2-3: What mechanisms could be applied to keep the cumulative
exposure to the lens of the eye below the threshold of 0.50 Gy (50
rad)?
Q2-4: What methods should be allowed for measurement or assessment
of the dose to the lens of the eye?
Q2-5: What methods should be allowed for recording dose to the lens
of the eye when the eyes are protected?
Q2-6: What are the potential operational impacts of lowering the
annual occupational dose to the lens of the eye from the current NRC
regulatory standard of 150 mSv (15 rem) to 50 mSv (5 rem)? Would a
reduction in the occupational dose limit for the lens of the eye
require changes in programs, procedures, practices (e.g., increased use
of protective eyewear), or in-room shielding? If so, please describe
these changes, including any potential implementation and operational
costs.
Q2-7: What are the potential impacts on State regulatory programs
of a reduction in the occupational dose limit to the lens of the eye
from the current NRC regulatory standard of 150 mSv (15 rem) to 50 mSv
(5 rem)?
C. Dose Limit for Embryo/Fetus of a Declared Pregnant Occupational
Worker
Currently, the NRC's regulations in 10 CFR 20.1208(a) set the dose
limit for the embryo/fetus of a declared pregnant worker at 5 mSv (500
mrem) for the entire pregnancy. Section 20.1208(d) provides allowances
for delays in the declaration of pregnancy by workers. If the dose
equivalent to the embryo/fetus has exceeded 5 mSv (500 mrem), or is
within 0.5 mSv (50 mrem) of this dose, at the time the worker declares
the pregnancy to the licensee, then the dose to the embryo/fetus cannot
exceed 0.5 mSv (50 mrem) for the remainder of the pregnancy (10 CFR
20.1208(d)). In addition, licensees are to make efforts to avoid
substantial variation above a uniform monthly exposure rate to satisfy
the dose limit (10 CFR 20.1208(b)). These requirements are based on the
ICRP Publication 26 (1977) recommendations. However, ICRP Publication
103 (2007) recommends that the dose limit for the embryo/fetus of a
declared pregnant worker be the same as that for a member of the
public, which is 1 mSv (100 mrem).
Prior to the 1991 amendments to 10 CFR part 20, the NRC's
regulations did not contain a specific dose limit for the embryo/fetus
of a declared pregnant occupational worker. Instead, as a matter of
policy, the NRC used a single annual limit for both genders and relied
on information in Regulatory Guide 8.13, ``Instruction Concerning
Prenatal Radiation Exposure,'' which was first issued in March 1975
(ADAMS under Accession No. ML13350A220) to maintain exposures to the
embryo/fetus ALARA.
In developing Regulatory Guide 8.13, the Commission considered the
recommendations in NCRP Report No. 39 (1971), ``Radiation Protection
Criteria.'' The NCRP recommended that during the entire gestation
period, the maximum permissible dose equivalent to the embryo/fetus
from occupational exposure of the worker should not exceed 5 mSv (500
mrem). The ICRP Publication 26 (1977) recommended limiting the working
conditions of the declared pregnant worker in such a manner that it is
unlikely that the embryo/fetus would receive a dose greater than 5 mSv
(500 mrem) for the entire gestation period (51 FR 1092; January 9,
1986).
Thousands of pregnant women are occupationally exposed to ionizing
radiation each year. There are radiation-related risks throughout
pregnancy that are related to the stage of pregnancy and absorbed dose.
Exposure of the embryo/fetus to ionizing radiation could cause adverse
health effects, such as cancer and developmental abnormalities. The
susceptibility of the embryo/fetus to damage by radiation is well
established and data suggests that the period from 10 weeks to 17 weeks
in the development of a fetus may be especially critical. Because of
this susceptibility, limiting the dose to the embryo/fetus to 5 mSv
(500 mrem) or less during the entire pregnancy is generally considered
desirable (51 FR 1092; January 9, 1986). Accordingly, the NCRP Report
54 (1977), ``Medical Radiation Exposure of Pregnant and Potentially
Pregnant Women,'' recommended that the total dose equivalent to the
embryo/fetus from occupational exposure of the expectant mother not
exceed 5 mSv (500 mrem), and that once the pregnancy is known, exposure
of the embryo/fetus not exceed 0.5 mSv (50 mrem) in any month.
The ICRP Publication 60 (1991) made clear that the embryo/fetus
should be regarded as a member of the public when considering the
protection of female workers who are or may be pregnant. In ICRP
Publications 60 (1991) and 103 (2007), the ICRP concluded that there is
no reason to distinguish between the genders for the purposes of
controlling occupational exposures. However, under the ICRP
recommendations, if a female worker declares her pregnancy, then
additional controls must be considered to protect the embryo/fetus. The
ICRP also stated that the methods of radiation protection for
occupational workers, who are or may be pregnant, should provide a
level of protection for the embryo/fetus equivalent to that provided
for a member of the public. The ICRP Publication 103 (2007) recommended
approach is that the working conditions of a pregnant worker, after
declaration
[[Page 43293]]
of pregnancy, should be such that it is unlikely that the additional
dose to the fetus would exceed about 1 mSv (100 mrem) during the
remainder of pregnancy.
On May 24, 2013, NCRP Report No. 174, ``Preconception and Prenatal
Radiation Exposure: Health Effects and Protective Guidance,'' was
released. It updated and expanded upon the information in NCRP Report
No. 54. The report noted that scientific knowledge has increased and
public concerns have changed in the past 36 years since NCRP Report No.
54 was published. Like the findings of ICRP Publication 103 (2007), the
report recommended a dose limit of 1 mSv (100 mrem), including dose
from the intake of radionuclides, to the embryo/fetus of a declared
pregnant worker and recommended applying the concept of ALARA to these
exposures.
Although the assessment of doses to the embryo/fetus from exposures
to external radiation can be related directly to exposures of the
pregnant worker, assessment of doses from intakes of radionuclides is
not straightforward. Doses to the embryo/fetus may result from the
inhalation or ingestion of radionuclides by the mother during or before
pregnancy, and additional doses to the newborn child may result from
the transfer of radionuclides in breast milk. The ICRP publications
provide dose coefficients for the offspring (embryo/fetus and newborn
child) following radionuclide intake by the mother before or during
pregnancy and during breast feeding. In many important cases of
potential radionuclide intake, doses to the offspring may exceed doses
to the mother; such cases should be taken into account in the
development of radiation protection programs.\26\
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\26\ See ICRP Publication 60 (1991); ICRP Publication 75 (1997),
``General Principles for the Radiation Protection of Workers;'' and
ICRP Publication 96 (2005), ``Protecting People against Radiation
Exposure in the Event of a Radiological Attack.''
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To provide adequate radiation protection for the embryo/fetus, and
to minimize the restriction on employment, the NRC recognized the
importance of female workers voluntarily informing their employers of
their pregnancy and the estimated date of conception, so that
arrangements can be made to restrict potential exposures. The pregnant
worker has the fundamental responsibility for deciding when or whether
she will formally declare her condition to her employer. This position
is derived from court rulings concerning a woman's rights regarding
pregnancy. Having a formal declaration of pregnancy derives from legal,
not health protection, considerations (56 FR 23373; May 21, 1991). If
an occupational worker chooses not to declare her pregnancy, then the
licensee will not be required under the Commission's regulations to
limit her dose to the 5 mSv (500 mrem).
The undeclared pregnant occupational women are protected under the
NRC's regulations for all workers. The normal occupational dose limits
would still be in effect and would have to be complied with, and the
dose would also have to be kept ``as low as is reasonably achievable.''
In addition, as part of her initial employment, the woman, like all
occupational workers, should receive instructions in radiation
protection (10 CFR 19.12), and a copy of the current version of
Regulatory Guide 8.13 (56 FR 23373; May 21, 1991).
The ICRP Publication 103 (2007) recommends that the dose to the
embryo/fetus of a declared pregnant worker provide the same general
level of protection as that offered for a member of the public, which
is 1 mSv (100 mrem). The ICRP recommends applying the 1 mSv (100 mrem)
criterion after the declaration of pregnancy by the occupational
worker.
The NRC has determined that it is appropriate and scientifically
justified to explore whether to change the dose limit for the embryo/
fetus to 1 mSv (100 mrem). In its 1991 final rule that amended 10 CFR
part 20, the NRC changed the dose limit for a member of the public from
5 mSv (500 mrem) to 1 mSv (100 mrem); however, it did not make the
corresponding change to the dose limit for the embryo/fetus. Lowering
the dose limit for the embryo/fetus of a declared pregnant occupational
worker would align the NRC's regulatory requirements with current
scientific data. The data indicate that the embryo/fetus is more
sensitive to radiation than initially surmised. This approach would
also align the NRC's regulations with the ICRP Publication 103 (2007)
recommendations. The option of applying the limit over the entire
gestation period, or only to the portion of time following declaration,
would need to be explored in greater detail.
The Issue Paper 3, ``Dose Limit for the Embryo/Fetus of a Declared
Pregnant Occupational Worker,'' provides a more detailed discussion and
is available in ADAMS under Accession No. ML14084A339. In addition, the
following questions are intended to elicit information from the public,
the regulated community, and other stakeholders to obtain this
information.
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? What are the potential
implementation and operational costs?
Q3-2: Are there any benefits or impacts associated with applying
the reduced dose limit over the entire gestation period, or only to the
period after declaration?
Q3-3: Are there any anticipated implementation impacts on
recordkeeping if the dose limit to the embryo/fetus is lowered to 1 mSv
(100 mrem)? What are the potential implementation and operational
costs?
Q3-4: Are there technological implementation issues, such as limits
of detection, which would make adoption of the ICRP Publication 103
(2007) recommendation difficult in certain circumstances?
Q3-5: Are there data on actual dose distributions to the embryo/
fetus of a declared pregnant worker? What are the trends for these
data?
D. Individual Protection--ALARA Planning
Each NRC licensee is required to develop, document, and implement a
radiation protection program commensurate with the scope and extent of
its licensed activities.\27\ In addition to meeting expressed dose
limits, the NRC requires its licensees to apply the ALARA principle to
their licensed operations. Section 20.1003 defines the term ALARA as
``making every reasonable effort to maintain exposures to radiation as
far below the dose limits in this part [10 CFR part 20] as is practical
consistent with the purpose for which the licensed activity is
undertaken . . .'' \28\ The NRC's current ALARA requirements are
provided in subpart B of 10 CFR part 20, ``Radiation Protection
Programs,'' and are contained in 10 CFR 20.1101(b) and (d). The current
occupational dose limits are provided in subpart C of 10 CFR part 20,
``Occupational Dose Limits,'' and 10 CFR 20.1201 provides the
occupational dose limits for adults.
---------------------------------------------------------------------------
\27\ 10 CFR 20.1101(a).
\28\ 10 CFR 20.1003 (definition of ``ALARA (acronym for `as low
as is reasonably achievable' '').
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In the United States, the majority of occupationally exposed
individuals receive less than 20 mSv (2 rem) per year as reported to
the NRC.\29\ However,
[[Page 43294]]
a small percentage of individuals receive larger exposures up to, and
occasionally above, the NRC's current annual occupational limit of 50
mSv (5 rem). While nuclear power reactor operators have been successful
in reducing individual exposures, such that only a very limited number
of individuals exceed 20 mSv (2 rem) in a year,\30\ this is not the
case in other segments of the regulated community. For example,
industrial radiographers have a somewhat greater percentage of
individuals above the average annual dose level of 20 mSv (2 rem)
recommended in ICRP Publication 103 (2007). Stakeholder interactions
have led the NRC staff to conclude that some of these individuals may
be receiving doses close to the 50 mSv (5 rem) limit over multiple
years. As described in Section IV.E. of this ANPR and Issue Paper 6,
``Reporting of Occupational Exposure'' (ADAMS Accession No.
ML14084A344), detailed information on these cumulative exposures is
difficult to ascertain because some segments of the regulated community
are not required to report occupational exposure, therefore making it
difficult ``to assure that lifetime exposure of workers repeatedly
exposed near the limits is minimized'' (52 FR 2822; January 27, 1987).
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\29\ NUREG-0713, ``Occupational Radiation Exposure at Commercial
Nuclear Power Reactors and Other Facilities 2011'' (ADAMS Accession
No. ML13095A191).
\30\ NCRP Report No. 160, ``Ionizing Radiation Exposure of the
Population of the United States,'' 2009.
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The NRC's regulation in 10 CFR 20.1101(b) provides that each
licensee ``shall use, to the extent practical, procedures and
engineering controls based upon sound radiation protection principles
to achieve occupational doses and doses to members of the public that
are as low as is reasonably achievable (ALARA).'' The NRC's current
regulations in 10 CFR part 20 do not include an explicit requirement to
plan activities to optimize radiation protection (ALARA planning) or to
establish ALARA planning values as part of the licensee's radiation
protection program. With respect to nuclear power reactors, the NRC
staff has issued Regulatory Guide 8.8, Revision 3, ``Information
Relevant to Ensuring that Occupational Radiation Exposures at Nuclear
Power Stations Will Be As Low As Is Reasonably Achievable'' (ADAMS
Accession No. ML003739549), which describes methods to implement the
existing ALARA requirements, including detailed ALARA planning for use
in the operations of commercial power reactors. However, this level of
ALARA planning is not as common in the programs of other types of NRC
licensees.
The NRC notes that its implementation and enforcement of its ALARA
principles are generally made through specific license conditions
instead of through more detailed regulations. Therefore, the NRC staff
questions whether additional regulatory requirements are appropriate to
foster a clear and consistent approach for all types of licensees
versus relying upon license conditions.
In SRM-SECY-12-0064, dated December 17, 2012 (ADAMS Accession No.
ML12352A133), the Commission directed the NRC staff to continue
discussions with stakeholders on alternative approaches to deal with
individual protection at or near the current dose limit. The NRC is
currently examining possible mechanisms for addressing individual
protection at, or near, the current occupational dose limit of 50 mSv
(5 rem) per year. One potential mechanism for achieving this goal is to
revise 10 CFR 20.1101, ``Radiation Protection Programs,'' to include
additional requirements for implementing ALARA. Furthermore, reducing
exposures through consistent ALARA implementation is a straight forward
method for addressing concerns about a worker receiving a cumulative
occupational dose, at or near the dose limit, over a number of years.
In addition, the NRC is interested in other proposals for
addressing individual protection at or near the current dose limit.
During previous public interactions, some stakeholders expressed an
interest in strengthening the current ALARA requirements, whereas
others expressed opposition to any additional requirements. Some
stakeholders who opposed additional ALARA requirements expressed
concerns that such additional requirements would become de facto limits
and would inhibit the flexibility of licensees to deal with specific
operational circumstances.
The NRC staff believes that the objective of any additional
regulatory requirements should be to ensure the accurate monitoring of
an individual's cumulative occupational dose and to ensure that
progressive measures to reduce dose are taken, if necessary, as the
cumulative dose increases. If the NRC determines that additional
regulatory requirements are necessary to limit the cumulative
occupational dose, then this objective could be achieved through either
performance-based requirements, such as ALARA, prescriptive
requirements, or both. Performance-based requirements express or
describe the particular outcomes that must be achieved while leaving
some discretion to a licensee on the specific mechanisms used to
achieve those outcomes. On the other hand, prescriptive requirements
specify a particular methodology or action that is necessary for
compliance.
The establishment of ALARA planning values in administrative
control levels, relative to the implementation of the ALARA principle,
is not a new concept. The ``Federal Radiation Protection Guidance for
Occupational Exposure'' (52 FR 2822, January 27, 1987; ADAMS Accession
No. ML13269A320), provides a set of recommendations that incorporates
this concept. The NRC and several other Federal agencies developed
these recommendations, which were approved by President Reagan on
January 20, 1987. The guidance states, ``Federal radiation guidance can
address only the broad prerequisites of an effective ALARA program . .
. authorities may find it useful to establish or encourage the use of .
. . administrative control levels specifying, for specific categories
of workers or work situations, dose levels below the limiting numerical
values recommended in this guidance.''
The current regulations do not require licensees to have a
structured ALARA planning process. Therefore, the NRC is considering
the development of a requirement for ALARA radiation protection
planning. This additional ALARA planning requirement would provide a
basis to ensure that licensees have an ongoing process to review
radiation exposures, to consider if changes are warranted and practical
to reduce exposures, and to ensure the implementation of appropriate
programmatic changes.
In conjunction with developing a requirement for ALARA planning,
the NRC is considering developing a mechanism to address additional
protection when an individual occupational worker nears his or her
annual dose limit, and developing cumulative dose criterion that would
control doses that an individual worker may receive over a multiple-
year period. In this regard, the NRC would require each licensee, as a
part of its radiation protection program, to establish mechanisms to
examine cumulative occupational doses, and to implement control
measures limiting additional doses if an occupational worker approaches
his or her cumulative dose criterion. If the NRC ultimately issues such
a requirement, it would develop associated guidance to address the
various types of licensed activities.
[[Page 43295]]
Specifically, regulatory guidance could describe the types of
methodologies that the NRC staff could consider acceptable to meet the
regulatory requirement of controlling dose as an individual
occupational worker approaches the annual dose limit, or his or her
cumulative dose criterion. The NRC is considering using various
methodologies that are based on national and international
recommendations. One potential methodology could be for a licensee to
use the ICRP Publication 103 (2007) recommendations for an average dose
over a 5-year period of 20 mSv (2 rem) as an administrative control
level (ACL).\31\ If no individual at the licensed facility exceeded the
ACL on an annual basis, then no additional actions would be needed by
the licensee other than continued monitoring of exposures. However, if
an individual exceeded the ACL in any particular year, the licensee
could commit to tracking and limiting the dose of that worker over a 5-
year period; the licensee would need to maintain the cumulative
occupational dose records during this period.
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\31\ The 1987 ``Federal Radiation Protection Guidance for
Occupational Exposure'' defines an ``administrative control level''
as a requirement ``determined by a competent authority of the
management of an institution or facility. They are not primary
limits, and may therefore be exceeded, upon approval of competent
authority or management, as situations dictate'' (52 FR 2833;
January 27, 1987).
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A second potential methodology for establishing an ACL could be
based on the NCRP Report 116, ``Limitation of Exposure to Ionizing
Radiation,'' which recommended an age based cumulative dose
restriction. The NCRP Report 116 recommended an occupational dose limit
of 50 mSv (5 rem) per year and a cumulative occupational dose limit of
10 mSv (1 rem) times the individual's age in years. Therefore, a
licensee could establish an ACL at the 10 mSv (1 rem) level, and if
this level is exceeded in any one year, the licensee would apply
cumulative dose tracking to ensure that the cumulative age based dose
limit for the individual is not exceeded.
In a third potential methodology, a licensee could establish an ACL
based on lifetime exposures instead of the yearly approach to dose
limits as in ICRP or NCRP recommendations. Under this approach, a
licensee could commit to tracking the cumulative occupational doses for
each worker and to applying specific additional restrictions if the
cumulative occupational dose exceeded a set lifetime cumulative ACL
value. Example values of cumulative ACL, such as 0.5 Sv (50 rem) or
0.75 Sv (75 rem), over the worker's lifetime could serve as appropriate
fractions of the upper (tolerable) cumulative lifetime dose limit found
in ICRP and NCRP recommendations. This approach could work in
conjunction with regulations for cumulative occupational dose
recordkeeping requirements to ensure that licensees took appropriate
actions if dose limits are exceeded.
The preceding methodologies are presented as possible approaches
for implementing a general performance requirement. Alternatively, the
regulation could specifically incorporate one or more of these
methodologies as a new prescriptive requirement. The NRC is interested
in obtaining stakeholder input on the use of a performance or
prescriptive approach, the rationale as to why one approach is
preferable over the other, and any other alternatives that the NRC
should consider as acceptable.
The NRC is also considering whether an additional requirement is
necessary to address the question of concurrent occupational doses of
an individual working at multiple licensed facilities. Situations may
occur in which workers receive occupational exposures at more than one
facility concurrently. One approach could be to expand the scope of 10
CFR 20.2104(a) to cover workers' concurrent employment by two or more
licensees during the same period of time (e.g., a weekday shift at one
licensee's facility followed by a weekend shift at another licensee's
facility). Presently, the regulations require licensees to determine
the yearly occupational doses received by its workers. In this regard,
10 CFR 20.2104(c) could be revised to add the phrase ``and any
concurrent'' to statements that now only specify the individual's most
recent employer.
As discussed previously, before the 1991 amendments to 10 CFR part
20, the NRC's regulatory framework included the formula D=5 (N-18),
where ``N'' is the person's age in years, and where ``D'' is the
lifetime dose limit in rems.\32\ As part of the implementation of this
former regulation, workers were required to provide NRC Form 4,
``Cumulative Dose History Report,'' when reporting to a new facility.
However, the 1991 amendments to 10 CFR part 20 removed this requirement
and the lifetime dose limit formula. The statement of considerations
for the 1986 proposed rule (which led to the 1991 final rule) explains
the lifetime dose limit formula was eliminated as a measure to reduce
annual and lifetime doses to occupational workers (51 FR 1092, 1121;
January 9, 1986). As a result, there is now no requirement in the NRC's
regulations for a licensee to receive a cumulative dose history report
(NRC Form 4 or equivalent) from a new employee.
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\32\ The former regulation, 10 CFR 20.101(b)(2), stated ``[t]he
dose to the whole body, when added to the accumulated occupational
dose to the whole body, shall not exceed 5 (N-18) rems where `N'
equals the individual's age in years at his last birthday.'' The
1991 rulemaking revised and renumbered the NRC's radiation
protection regulations in 10 CFR part 20.
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The various types of radioactive material licenses pose different
challenges to the control of occupational doses (e.g., industrial
radiography, nuclear medicine). In some situations, the design and
operation associated with the use of radioactive material limits the
occupational dose. Conversely, some uses of radioactive materials can
result in significant occupational doses that may be near the annual
dose limit. Therefore, the spectrum of radioactive material licenses
presents a wide range of challenges and opportunities for reducing
occupational doses under ALARA provisions, especially when exposures
approach the limits. The NRC is seeking to understand how to ensure
that a greater focus is placed on keeping occupational doses ALARA,
consistent with the wide range of uses of radioactive material that are
licensed. The NRC also seeks to understand the potential impacts of the
methodologies that were previously discussed, including any potential
difficulties associated with implementation if such methodologies were
made requirements by rulemaking.
The Issue Paper 4, ``Individual Protection--ALARA Planning,''
provides more detailed information and is available in ADAMS under
Accession No. ML14084A340. In addition, the following questions are
intended to elicit information from the public, the regulated
community, and other stakeholders to obtain this information.
Questions
Q4-1: What are the potential implications of adding specific ALARA
planning and implementation requirements to the 10 CFR part 20
regulations? What changes to licensee radiation protection programs
could be anticipated? What would be the potential implementation and
operational costs?
Q4-2: What regulatory language should be used for an additional
ALARA planning requirement and what is the rationale for this language?
Q4-3: How does each of the described methodologies for addressing
when an individual occupational worker approaches his or her cumulative
dose for the year work for different classes of
[[Page 43296]]
licensed uses (e.g., a worker at a nuclear reactor power plant versus
an industrial radiographer versus medical personnel)? What are the
benefits and impacts of the various approaches to ALARA planning on the
various types of licenses?
Q4-4: Should licensees be allowed to establish different ACLs for
different groups of occupational workers? If so, what should be the
basis for the various groupings?
Q4-5: How do the different methodologies previously discussed
impact the ability of licensees to best address radiation protection
within their programs?
Q4-6: Other than the methodologies discussed in the preceding
section, are there other ways to evaluate occupational lifetime
cumulative exposures that should be considered?
Q4-7: What are the potential impacts to licensees, contractors, and
dosimetry vendors of amending 10 CFR 20.2104 to require a licensee to
account for exposure from an occupational worker's concurrent
employment with another licensee? Are there any dosimetry vendors that
provide concurrent dose records? Should the NRC consider provisions
that would require individual occupational workers to provide their
occupational dose information in addition to requiring such information
from licensees?
Q4-8: Should the Agreement States be allowed to use more
restrictive or prescriptive requirements if the NRC decides to use a
performance-based approach? What are the benefits and impacts of the
various methodologies discussed in the preceding section on Agreement
State regulatory programs and Agreement State licensees? If the NRC
issues a proposed rule, this information will be important in
establishing an appropriate Agreement State compatibility level for any
proposed regulatory requirements.
E. Metrication--Units of Radiation Exposure and Dose
The current 10 CFR part 20 radiation protection regulations were
promulgated approximately 1 year before to the publication of the NRC's
metrication policy (57 FR 46202; October 7, 1992). The metric system is
also known as the International System of Units (SI). Therefore, most
NRC dose limits and other units of measurements are listed in the
regulations with the traditional or ``English'' (also known as non-SI)
units first followed by the metric units in parentheses. Some NRC
regulations list metric units first followed by traditional or
``English'' units in parentheses. Numerical information in the
appendices to 10 CFR part 20 is a mixture of traditional and metric
units. For example, the DACs in 10 CFR part 20, appendix B, Table 1,
are in units of microcuries per milliliter ([mu]Ci/ml); therefore, the
activity is in traditional units and the volume is in metric units. By
contrast, appendix C of 10 CFR part 20 only displays numerical
information using the traditional units of measurement.
In SRM-SECY-12-0064, the Commission disapproved the elimination of
traditional units from the NRC's regulations. The SRM further stated
that both the traditional and SI units should be maintained. Pursuant
to the NRC's 1992 metrication policy, the NRC supports and encourages
the use of the metric system of measurement by the nuclear industry.
The 1992 policy directed the NRC staff, beginning in 1993, to publish
the following documents in dual units of measurement with the SI units
listed first followed by the ``English'' units in parentheses: New
regulations, major amendments to existing regulations, regulatory
guides, NUREG-series documents, policy statements, information notices,
generic letters, bulletins, and all written communications directed to
the public. In addition, the NRC's policy provided that licensee-
specific NRC documents, such as licensee inspection reports and
licensee-specific docketed material, use the system of measurements
utilized by the licensee. Furthermore, the policy provided that all
event reporting and emergency response communications between
licensees, the NRC, and State and local authorities will use the
traditional units of measurement. In a 1996 review of its 1992
metrication policy, the Commission stated that it does not intend to
revisit the 1992 policy unless it is shown to cause an undue burden or
hardship (61 FR 31169, 31171; June 19, 1996).
The implementation of the NRC's metrication policy is not
consistent with respect to the units of measurement used in
recordkeeping and reporting. The NRC's regulations in 10 CFR
20.2101(a), ``Records,'' currently require licensees to use the
traditional units. Therefore, licensees cannot use the metric units
even if they wanted to do so. Section 20.2101(b) allows licensees to
record quantities in SI units in parentheses after the traditional
units. Section 20.2101(c) requires information recorded on shipping
manifests, (e.g., shipments to low-level waste disposal facilities) as
required by 10 CFR 20.2006(b), to be listed in SI units or both SI and
traditional units. In addition, some NRC regulations require licensee
reports to present information with the traditional units first
followed by the SI units in parentheses.
The requirement to keep all records in traditional units, or in
both sets of units, could be seen as inconsistent with a revised
regulation in which the dose criteria are expressed first in SI units
followed by the traditional units. One alternative could be to amend
the regulations to allow a licensee to maintain records in either set
of units as long as only one set of units was used throughout a
licensee's recordkeeping system. Another alternative could be to allow
a licensee to use either set of units in measurements and calculations;
however, the licensee would be required to present the final values
that support regulatory compliance in one or both sets of units. These
various alternatives have different regulatory burdens and
implementation issues. The NRC staff is seeking to gain additional
information from stakeholders on the implications of the various
alternatives, including the option that no change should be made.
As part of its draft regulatory basis development for a possible
revision to the 10 CFR part 20 regulations, the NRC staff is examining
the implementation of the Commission's metrication policy about how
numerical material could be presented in appendix B of 10 CFR part 20.
The NRC staff believes that the unique nature of appendix B, with its
detailed numeric information for each radionuclide, may pose a
situation in which a deviation from the metrication policy may be
needed.
Two issues need to be addressed regarding the application of the
Commission's metrication policy to appendix B to 10 CFR part 20. The
first issue is the selection of the value that the NRC will consider as
the regulatory standard. The values in appendix B are currently given
in traditional activity units (microcuries ([mu]Ci)) with a certainty
of one significant digit. One microcurie is equal to 3.7 x 10\4\
becquerels (Bq) in the SI units; therefore, the conversion from
microcurie to becquerel is completed by multiplying the activity in
microcuries by 3.7 x 10\4\. The resulting values in SI units
(becquerels) could be more or less restrictive than the original
microcurie values depending on the number of significant digits to
which the value is rounded. For example, currently appendix B to 10 CFR
part 20 provides the oral ingestion ALI for Actinium-224 as 2 x 10\4\
[mu]Ci. The corresponding value in the SI units before rounding to one
significant digit is 7.4 x 10\7\ Bq. If rounded to one significant
digit, using the standard rounding conventions, the value in Bq would
be smaller than the value in microcurie, and would be more
[[Page 43297]]
restrictive. Therefore, the NRC staff is exploring the implications of
stating the numerical values in appendix B of 10 CFR part 20 like that
used in in appendix A to 10 CFR part 37, ``Physical Protection of
Category 1 and Category 2 Quantities of Radioactive Materials.''
In the development of appendix A to 10 CFR part 37, the NRC stated
that the SI units provided the regulatory standard and the traditional
units were provided for practical use only. Appendix A to 10 CFR part
37 provides in column 1 the name of the radioactive material, column 2
provides the source activity in terabecquerel (TBq), and column 3
provides the source activities in curies. In appendix A to 10 CFR part
37, the NRC also chose to forgo the conventional rounding to the
nearest whole number or the rounding to the first significant figure
after the decimal point. Rather, appendix A to 10 CFR part 37, column 3
lists curie activity equivalents as three significant figures because
many NRC licensees use curies instead of becquerels for source
radioactivity. The 10 CFR part 37 -approach of rounding to three
significant figures greatly reduces any discrepancies between the two
values (the source strength in curies and the source strength in
becquerels).
The second issue is the presentation of numerical information in
the appendices to 10 CFR part 20. If the NRC staff implements the
Commission's metrication policy in appendix B to 10 CFR part 20 (i.e.,
SI units listed first followed by traditional units in parentheses),
the table could become more complicated. At present, appendix B of 10
CFR part 20 consists of three columns providing each radionuclide's
name, symbol, and the solubility class, followed by six additional
columns providing each radionuclide's ALIs and DACs, concentration
limits for airborne and liquid effluents released to the general
environment, and concentration limits for discharges to sanitary sewer
systems in microcuries or microcuries per milliliter. Implementation of
the metrication policy would effectively add six additional columns to
provide the traditional unit numeric counterpart for each value in
parentheses next to the corresponding values in the SI units. An
alternative could be to publish the traditional unit values in a
separate guidance document for the convenience of users; this
alternative would an exception to the Commission's metrication policy.
The NRC staff is interested in stakeholder views on potential
options on the application of the Commission's metrication policy to
any potential 10 CFR part 20 revisions. Specifically, the NRC staff is
seeking input on: (1) What are some of the potential options; (2) what
are the impacts of the option on the format and the usefulness of the
NRC's regulations; and (3) what are some of the impacts of the option
on licensee operations, especially any benefits, burdens, or undue
hardship. Using two units of measurements, traditional and SI units has
the potential for causing communication challenges. Therefore, the NRC
staff is interested in the implications and impacts of aligning any
potential revisions to 10 CFR part 20 with the Commission's existing
metrication policy, and with other possible changes that could be
considered as aligning to such a change.
The Issue Paper 5 ``Metrication--Units of Radiation Exposure and
Dose,'' provides more detailed information and is available in ADAMS
under Accession No. ML14084A343. In addition, the following questions
are intended to elicit information from the public, the regulated
community, and other stakeholders.
Questions
Q5-1: Will promulgation of amendments to the 10 CFR part 20
regulations with dose limits and other measurements shown in dual
units, with the SI units shown first, followed by the traditional units
in parentheses, cause an undue burden or hardship upon any licensee or
class of licensees? If so, please explain and provide examples,
including any potential implementation or operational costs.
Q5-2. Should 10 CFR 20.2101(a) be revised to allow licensees the
option of providing records in SI units or in traditional units? Should
licensees be allowed to provide reports in the units used in licensee
records? Should licensees be required to record and report in both sets
of units? Please provide reasons why or why not.
Q5-3. Should the NRC amend the appendices for 10 CFR part 20 to
show values in SI units only, in traditional units only, or in both
sets of units? If both SI and traditional units are provided, which set
of units should be considered as the regulatory standard? If only one
set of units is specified, what would be the most effective means to
provide the other set of units (e.g., in a separate guidance
publication)? Please provide reasons why or why not.
F. Reporting of Occupational Exposure.
On December 19, 1968, the AEC published an amendment to 10 CFR part
20 in the Federal Register (33 FR 18926) that added new 10 CFR 20.407,
``Personnel exposure and monitoring reports.'' \33\ This new section
required the reporting of occupational radiation exposure information
to a central repository at AEC headquarters. The amendment required
four categories of licensees to report: (1) Commercial nuclear power
reactors, (2) industrial radiographers, (3) fuel processors and
fabricators, and (4) manufacturers and distributors of byproduct
material. The Commission considered these licensees to have the
greatest potential for significant occupational doses. The AEC
established this reporting requirement to assist in the following
actions: (1) Identifying those individuals who are monitored by more
than one licensee or AEC contractor, (2) analyzing radiation exposure
experience and identifying general exposure trends from year to year,
(3) analyzing the exposure experience of AEC contractors and the four
listed categories of licensees, (4) initiating appropriate remedial
action where trends or experience in increased radiation exposures
indicate the need for more effective controls, and (5) considering and
developing appropriate modifications to radiation protection standards
and requirements.
---------------------------------------------------------------------------
\33\ In a final rule dated September 29, 1978 (43 FR 44827,
44829), the NRC renumbered 10 CFR 20.407 as 10 CFR 20.408. Section
20.408 later became the basis for current 10 CFR part 20 reporting
regulation, 10 CFR 20.2206, which lists seven categories of
licensees required to submit an annual report of the results of
individual monitoring of occupational exposure.
---------------------------------------------------------------------------
On January 19, 1975, the NRC was formed and on May 30, 1975, the
NRC published a proposed rule in the Federal Register (40 FR 23478)
that would require all NRC-specific licensees to submit personnel
monitoring data to the agency. By a letter dated June 2, 1975 (43 FR
44827), a copy of the notice of the proposed rule was mailed to all
NRC-specific licensees (e.g., well loggers, medical and academic
institutions, industrial radiographers, and portable gauge users).
Thirty-six comments were received on the proposed rule. The majority of
the comments supported the proposed rule, but offered suggestions for
improvement. Medical licensees raised the majority of the opposition to
the proposed rule. Their opposition was based on the following issues:
(1) Additional paperwork would increase the cost of health care; (2)
the personnel monitoring data might have theoretical value, but no
practical value; (3) the NRC failed to demonstrate a sufficient cost
versus benefit ratio for another administrative requirement; (4)
occupational exposures (in medical diagnosis and therapy) are already
ALARA; (5) the requirements for
[[Page 43298]]
reporting overexposures are adequate; (6) only licensees with repeated
overexposures should be required to submit annual reports; (7)
separating exposures received from NRC-licensed material from exposures
received from non-NRC-licensed materials is not possible; and (8)
personnel monitoring data contain inherent inaccuracies.
In response to these comments, in a letter dated August 25, 1976,
the NRC requested that all NRC-specific licensees voluntarily submit
personnel monitoring data for calendar year 1975, along with the total
cost for preparing the data in man-hours and dollars-cents. The
licensees' responses indicated a total man-hours cost median of 2.75
minutes, and $0.65 per monitored individual to collect the requested
information (NUREG-0419, ``Occupational Radiation Exposure at NRC-
Licensed Facilities 1975, Office of Standards Development, U.S. Nuclear
Regulatory Commission'').
After a series of amendments in the 1980s, the occupational
reporting requirements in 10 CFR part 20 eliminated the provisions for
all NRC-specific licensees to submit reports, and expanded the license
reporting categories from four to the current seven, which are: (1)
Commercial nuclear power reactors, (2) industrial radiographers, (3)
fuel processors and fabricators, (4) manufacturers and distributors of
certain byproduct material, (5) geologic repositories for high-level
waste (HLW), (6) independent spent fuel storage installations (ISFSIs)
and (7) facilities for the land disposal of low-level waste (LLW) (46
FR 13978, February 25, 1981; 46 FR 58282, December 1, 1981; and 47 FR
57480, December 27, 1982).
The current occupational reporting provisions were moved to 10 CFR
20.2206, ``Reports of Individual Reporting,'' as a part of the 1991
amendments to 10 CFR part 20. Section 20.2206 requires seven categories
of licensees to provide an annual report of the monitoring of
occupational dose each April 30th (covering the prior calendar year) to
the NRC's REIRS database. At present, five categories of NRC licensees
report information to the database, namely: (1) Commercial nuclear
power reactors; (2) industrial radiographers; (3) fuel processors
(including uranium enrichment facilities), fabricators, and
reprocessors; (4) ISFSIs; and (5) manufacturers and distributors of
certain byproduct material. The NRC's REIRS database does not include
occupational information for the two other reporting categories, LLW
and HLW facilities, because the NRC has no licensees in those
categories. As a result, the database provides a system for maintaining
all relevant occupational doses received at nuclear power reactors,
fuel processors and fabricators, and ISFSIs in the United States,
because all of these facilities are licensed by the NRC regardless of
whether they are (even if located in an Agreement State).
Currently, a reporting gap exists because industrial radiographers,
and manufacturers and distributors of certain byproduct material, who
hold Agreement State licenses, instead of NRC licenses, are not subject
to the reporting requirements in 10 CFR 20.2206. As described in the
following paragraphs and Section VII.B., Issue Paper 6, ``Reporting of
Occupational Exposure'' (ADAMS Accession No. ML14084A344), Agreement
States are not required to adopt the provisions in 10 CFR 20.2206.
Consequently, the NRC has experienced significant difficulty in
developing reasonable assessments of the overall occupational doses
received from industrial radiographers, and manufacturers and
distributors of certain byproduct material, since the majority of these
licensees are regulated by Agreement States. In addition, as identified
in the chart in Section V of Issue Paper 6, several categories of NRC
radioactive material licensees are not subject to the 10 CFR 20.2206
reporting requirements. Therefore, the NRC lacks occupational exposure
data for several categories of radioactive material licensees.
The NRC's regulations in 10 CFR 20.2206(b) require certain
categories of NRC licensees to submit an annual report of the results
of the monitoring required by 10 CFR 20.1502 to the NRC's REIRS
database. The NRC does not require Agreement States to adopt the 10 CFR
20.2206 provisions. Although an Agreement State can choose not to
require their licensees to submit annual reports of occupational
radiation dose information to either itself or the NRC, some Agreement
State licensees voluntarily report occupational dose information to the
REIRS database.
In addition, to expand the Agreement State occupational radiation
dose information contained in the NRC's REIRS database, on August 6,
2010, the NRC sent a letter to Agreement State Radiation Control
Programs (ADAMS Accession No. ML102100390). This letter requested
Agreement State assistance in obtaining occupational radiation dose
information from their licensees in the categories of industrial
radiography and nuclear pharmacy for the monitoring period of 2000
through 2009.
During the period of 1997 through 2010, the NRC received
occupational dose reports from 312 Agreement State licensees. The 312
licensees represented less than 2 percent of the total number of
Agreement State licensees, at that time. The NRC staff review of the
reports indicated that the 312 Agreement State licensees monitored
exposures of 40,622 occupational workers, and 78 percent (31,704) of
these occupational workers received a measurable dose. The complete NRC
staff review is available in NUREG-2118, Vol.1, ``Occupational
Radiation Exposure at Agreement State-Licensed Materials Facilities,
1997-2010'' (ADAMS Accession No. ML12220A081).
Increased use of the NRC's REIRS database, could serve as a
national occupational exposure database for both the NRC and Agreement
States. If properly implemented, the database could correlate the
occupational exposure of an individual to the licensed facility where
the exposure was received. This information would be especially useful
for those workers who work concurrently at more than one licensed
facility, especially in the radioactive materials area. All of the
nuclear power plant licensees are regulated by the NRC, and are
required to report occupational exposures to the NRC's REIRS database.
Therefore, it is possible to determine the occupational doses of
nuclear workers that are employed at more than one nuclear facility,
including determining whether a person is exceeding the occupational
dose limits. However, there is no mechanism for the NRC or an Agreement
State to determine whether an individual is exceeding the occupational
dose limits as a result of concurrent employment at multiple licensed
facilities, especially if the individual works in jurisdictions
regulated by both the NRC and one or more Agreement States.
For example, a physician whose medical practice involves the use of
radioactive materials could work concurrently in Washington, DC (an NRC
jurisdiction), Alexandria, VA (an Agreement State jurisdiction), and
Bethesda, MD (a different Agreement State jurisdiction). If Agreement
State licensees provided reports to the NRC's REIRS database, then it
would be possible to ensure that an individual who is concurrently
employed by licensees in multiple jurisdictions does not exceed the
occupational dose limits.
Moreover, increased use of the NRC's REIRS database by NRC and
Agreement State licensees, could serve a vital function in evaluating
the overall effectiveness of the NRC's regulatory
[[Page 43299]]
programs, and could be used by the NRC and Agreement States in
inspection, enforcement, and incident response activities. It could
also assist in assessing cumulative occupational doses on a national
basis. The NRC staff is considering if new categories of licensees
should be required to report to the database and how to effectively
integrate any new reporting from NRC and Agreement State licensees into
the system. Therefore, the NRC staff is pursuing that a more detailed
examination of the implications, benefits, and costs of requiring
additional categories of licensees to report exposures to the NRC's
REIRS database. The Issue Paper 6, ``Reporting of Occupational
Exposures,'' provides a more detailed discussion of the background and
proposals on the reporting of occupational doses to the database
including a chart in Section V that lists several categories of NRC
radioactive material licensees where input is needed from the public.
In addition, the following questions are intended to elicit information
from the public, the regulated community, and other stakeholders.
Questions
Q6-1: What criteria should the NRC use to identify additional
categories of licensees that should be required to submit annual
occupational exposure reports under 10 CFR 20.2206(a)?
Q6-2: What are the benefits of collecting occupational exposure
information in one central database to assess the total annual
occupational exposure of those individuals who work at more than one
licensed facility or contractor facility during the calendar year and
receive occupational exposures at these facilities?
Q6-3: Should Agreement States be required to adopt regulations that
are compatible with the requirements in 10 CFR 20.2206?
Q6-4: Should the NRC consider a gradual expansion of the 10 CFR
20.2206 licensee reporting categories in a step-wise fashion (e.g.,
staggered compliance dates for different categories of licensees)? What
are the advantages or disadvantages for this option?
Q6-5: What are the potential implementation and operational costs
associated with expanding the occupational exposure reporting
requirements?
V. Public Meetings
The NRC plans to hold a series of Category 3 public meetings
specific to the six issues identified in this ANPR. The public meetings
will be held during the ANPR public comment period. The public meetings
will provide forums for the NRC staff to discuss the issues and
questions identified in the ANPR with external stakeholders and to
receive information to support development of a draft regulatory basis
for a potential revision of the radiation protection requirements in 10
CFR part 20. The NRC does not intend to provide detailed responses to
comments or other information submitted during the public meetings.
Each public meeting will be noticed on the NRC's public meeting Web
site at least 10 calendar days before the meeting. Stakeholders should
monitor the NRC's public meeting Web site for additional information
about the public meetings at https://www.nrc.gov/public-involve/public-meetings/index.cfm. The NRC will post the notices for the public
meetings and may post additional material related to this action to the
Federal rulemaking Web site at www.regulations.gov under Docket ID NRC-
2009-0279. The Federal rulemaking Web site allows you to receive alerts
when changes or additions occur in a docket folder. To subscribe: (1)
Navigate to the docket folder (NRC-2009-0279); (2) click the ``Sign up
for Email Alerts'' link; and (3) enter your email address and select
how frequently you would like to receive emails (daily, weekly, or
monthly).
VI. Cumulative Effects of Regulation
The NRC has implemented a program to address the possible
``cumulative effects of regulation'' (CER) in the development of
regulatory bases for rulemakings. The CER describes the challenges that
licensees or other impacted entities (such as Agreement States) may
face while implementing new NRC or other agency regulatory
requirements. The CER is an organizational effectiveness challenge that
results from a licensee or other impacted entity implementing a number
of complex positions, programs, or requirements within a prescribed
implementation period and with limited available resources, including
the ability to access technical expertise to address a specific issue.
The NRC is specifically requesting comment on the cumulative effects
that may result from a potential amendment to 10 CFR part 20. In
developing comments on the possible cumulative effects of any future 10
CFR part 20 rulemaking, please consider the following questions:
(1) In light of any current or projected CER challenges, what could
be considered as a reasonable effective date, compliance date, or
submittal date(s) from the time any potential final rule is published
to the implementation date of any new requirements, including changes
to programs, procedures, or facilities?
(2) If there are current or projected CER challenges, what could be
done to address them (e.g., if more time is anticipated to implement
the potential new requirements, what period of time is estimated to be
sufficient, and why would such a proposed time frame be necessary)?
(3) Please identify any current or projected regulatory actions by
the NRC or another regulatory agency (such as new or amended regulatory
requirements or orders) that could potentially influence the
implementation of any potential 10 CFR part 20 rulemaking?
(4) Are there any possible unintended consequences resulting from a
potential 10 CFR part 20 rulemaking, such as the possibility that this
potential rulemaking could create conditions that would be contrary to
the potential action's purpose and objectives? If so, what are the
anticipated consequences and how could they be addressed?
(5) Is there any potential costs and benefits information available
at this time on a potential 10 CFR part 20 rulemaking?
VII. 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 ANPR to be consistent with the Plain
Writing Act as well as the Presidential Memorandum, ``Plain Language in
Government Writing,'' published June 10, 1998 (63 FR 31883). The NRC
requests comment on this ANPR and the draft regulatory basis issues
papers (see Section VIII of this ANPR) with respect to the clarity and
effectiveness of the language used.
VIII. 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.
[[Page 43300]]
----------------------------------------------------------------------------------------------------------------
Document ADAMS accession No./Web link
----------------------------------------------------------------------------------------------------------------
The ICRP Publications referenced in this ANPR are https://www.icrp.org/publications.asp.
copyright protected. The NRC cannot reproduce or provide
copies of these documents. For additional information
regarding obtaining copies of ICRP Publications, please
see the ICRP Web site.
The NCRP Publications referenced in this ANPR are https://www.ncrponline.org/Publications/
copyright protected. The NRC cannot reproduce or provide Publications.html.
copies of these documents. For additional information
regarding obtaining copies of NCRP Publications, please
see the NCRP Web site.
Issue Paper 1: Update 10 CFR Part 20 to Align with ML14084A342.
International Commission on Radiological Protection
Publication 103 Methodology and Terminology.
Issue Paper 2: Occupational Dose Limit for the Lens of ML14084A341.
the Eye.
Issue Paper 3: Dose Limit for the Embryo/Fetus of a ML14084A339.
Declared Pregnant Occupational Worker.
Issue Paper 4: Individual Protection--ALARA Planning..... ML14084A340.
Issue Paper 5: Metrication--Units of Radiation Exposure ML14084A343.
and Dose.
Issue Paper 6: Reporting of Occupational Exposure........ ML14084A344.
A Review of the History of U.S. Radiation Protection ML050400427.
Regulations, Recommendations, and Standards,'' by C.G.
Jones, Health Physics Journal, February 2005, Vol. 88,
No. 2, pages 105-126.
SECY-01-0148, ``Processes For Revision of 10 CFR Part 20 ML011580363.
Regarding Adoption Of ICRP Recommendations On
Occupational Dose Limits And Dosimetric Models and
Parameters,'' dated August 2, 2001.
SRM-SECY-01-0148, ``Processes For Revision of 10 CFR Part ML021050104.
20 Regarding Adoption Of ICRP Recommendations On
Occupational Dose Limits And Dosimetric Models And
Parameters,'' dated April 12, 2002.
SECY-08-0197, ``Options To Revise Radiation Protection ML083360555.
Regulations And Guidance With Respect To The 2007
Recommendations of ICRP,'' dated December 18, 2008.
SRM-SECY-08-0197, ``Options To Revise Radiation ML090920103.
Protection Regulations And Guidance With Respect To The
2007 Recommendations of ICRP,'' dated April 2, 2009.
SECY-12-0064, ``Recommendations For Policy And Technical ML121020108.
Direction To Revise Radiation Protection Regulations And
Guidance,'' dated April 25, 2012.
SRM-SECY-12-0064, ``Recommendations For Policy And ML12352A133.
Technical Direction To Revise Radiation Protection
Regulations And Guidance,'' dated December 17, 2012.
Regulatory Guide 8.8, Revision 3, ``Information Relevant ML003739549.
to Ensuring that Occupational Radiation Exposures at
Nuclear Power Stations Will Be as Low as Is Reasonably
Achievable''.
DOE Technical Standard, DOE-STD-1196-2011, ``Derived ML13323B598.
Concentration Technical Standard''.
``Federal Radiation Protection Guidance for Occupational ML13269A320.
Exposure'' (52 FR 2822; January 27, 1987).
Regulatory Guide 8.13 ``Instruction Concerning Prenatal ML13350A220.
Radiation Exposure,'' March 31, 1975.
NUREG-0713, ``Occupational Radiation Exposure at ML13095A191.
Commercial Nuclear Power Reactors and Other Facilities
2011''.
NUREG-2118, ``Occupational Radiation Exposure at ML12220A081.
Agreement State-Licensed Materials Facilities,'' 1997-
2010.
----------------------------------------------------------------------------------------------------------------
X. Rulemaking Process
The NRC will consider comments received or other information
submitted in response to this ANPR in the development of the proposed
draft regulatory basis or any other documents developed as a part of
any potential 10 CFR part 20 rulemaking. The NRC, however, does not
intend to provide detailed responses to comments or other information
submitted in response to this ANPR. The information obtained through
this ANPR process will be used to develop a draft regulatory basis. The
draft regulatory basis will be published for public review and comment.
If the NRC develops a regulatory basis sufficient to support a proposed
rule, then there will be an opportunity for public comment when the
proposed rule is published and the NRC will respond to such comments if
and when it publishes a final rule. If the NRC develops draft
supporting guidance for a proposed 10 CFR part 20 rulemaking, then the
public, the regulated community, and other stakeholders will have an
opportunity to provide comment on the draft guidance.
If the NRC decides not to pursue a 10 CFR part 20 rulemaking on
this topic, the NRC will publish a document in the Federal Register
that will generally address public comments and withdraw this ANPR.
Dated at Rockville, Maryland, this 8th day of July 2014.
For the Nuclear Regulatory Commission.
Mark A. Satorius,
Executive Director for Operations.
[FR Doc. 2014-17252 Filed 7-24-14; 8:45 am]
BILLING CODE 7590-01-P
