[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]


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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.

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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 http://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 http://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 http://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 http://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\
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    \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.
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    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

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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.
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    \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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    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.
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    \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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    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).
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    \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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    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\
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    \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).
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    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\
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    \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,'' http://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.
---------------------------------------------------------------------------

    \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].''
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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 
(http://www.nrc.gov/reading-rm/basic-ref/glossary/cumulative-dose.html).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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'').
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \24\ The DOE standard uses the term ``newborn,'' while ICRP 
Publication 103 (2007) uses the term ``infant.''
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \25\ 10 CFR 20.1003, definition of ``Lens dose equivalent 
(LDE).''
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

    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' '').
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 http://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          http://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          http://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