[Federal Register Volume 72, Number 232 (Tuesday, December 4, 2007)]
[Rules and Regulations]
[Pages 68043-68059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23469]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 19, 20, and 50
RIN 3150-AH40
Occupational Dose Records, Labeling Containers, and the Total
Effective Dose Equivalent
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC or Commission) is
amending its regulations related to the reporting of annual dose to
workers, the definition of Total Effective Dose Equivalent (TEDE), the
labeling of certain containers holding licensed material, and the
determination of cumulative occupational radiation dose. This final
rule limits the routine reporting of annual doses to those workers
whose annual dose exceeds a specific dose threshold or who request a
report. This final rule also modifies the labeling requirements for
certain containers holding licensed material within posted areas in
nuclear power facilities. This final rule also amends the definition of
TEDE to be consistent with current Commission policy. Finally, this
rule removes the requirement that licensees attempt to obtain
cumulative exposure records for workers unless these individuals are
being authorized to receive a planned special exposure. These revisions
reduce the administrative and information collection burdens on NRC and
Agreement State licensees without affecting the level of protection for
either the health and safety of workers and the public, or for the
environment.
DATES: Effective Date: This final rule is effective on January 3, 2008.
ADDRESSES: Publicly available documents related to this rulemaking may
be viewed electronically on the public computers located at the NRC's
Public Document Room (PDR), Room O1F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee.
Publicly available documents created or received at the NRC are
available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/NRC/reading-rm/adams.html. From this site, the public can
gain entry into the NRC's Agencywide Document Access and Management
System (ADAMS), which provides text and image files of NRC's public
documents. If you do not have access to ADAMS or if there are problems
in accessing the documents located in ADAMS, contact the NRC's PDR
Reference staff at (800) 397-4209, (301) 415-4737, or by e-mail to
[email protected].
FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone (301) 415-4123; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
III. Summary and Analysis of Public Comments on the Proposed Rule
IV. Section-by-Section Analysis of Final Revisions
V. Agreement State Compatibility
VI. Availability of Documents
VII. Voluntary Consensus Standards
VIII. Environmental Impact: Categorical Exclusion
IX. Paperwork Reduction Act Statement
[[Page 68044]]
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis
XIII. Congressional Review Act
I. Background
The NRC Strategic Plan, Fiscal Year 2000-Fiscal Year 2005, included
among NRC performance goals for nuclear reactor safety, a performance
goal for reducing unnecessary regulatory burden on stakeholders.
Similarly, the NRC Strategic Plan Fiscal Year 2004-Fiscal Year 2009
includes as an Effectiveness Strategy improving NRC regulations by
adding needed requirements and eliminating unnecessary requirements.
The Strategic Plan defines unnecessary regulatory burden as
requirements that go beyond what is necessary and sufficient to provide
reasonable assurance that the public health and safety, environment,
and common defense and security will be protected.
To reduce unnecessary regulatory burden, the NRC issued a proposed
rule on September 22, 2006 (71 FR 55382), to revise 10 CFR 19.13,
``Notifications and Reports to Individuals,'' 10 CFR 20.1905,
``Exemptions to Labeling Requirements,'' and 10 CFR 20.2104,
``Determination of Prior Occupational Dose.'' The NRC also proposed to
revise the definition of TEDE in 10 CFR 20.1003, ``Definitions,'' and
10 CFR 50.2, ``Definitions,'' to be consistent with current Commission
policy.
The NRC received 16 comment letters in response to the proposed
rule. The commenters included a number of individuals; industry
organizations; and power reactor, uranium recovery, and fuel facility
licensees. A discussion of the issues raised by the commenters and the
Commission's response is covered below in Section III.
II. Discussion
This final rule includes four principal amendments. These revisions
are intended to reduce unnecessary regulatory burden on NRC and
Agreement State licensees without affecting the level of protection for
either the health and safety of workers and the public, or for the
environment. In finalizing this rule, no revisions were made to the
regulatory language that was published in the proposed rule (71 FR
55382; September 22, 2006).
A. Annual Dose Report to Workers
The first amendment revises paragraphs (b) and (d) of 10 CFR 19.13
and 10 CFR 20.2205, ``Reports to Individuals of Exceeding Dose
Limits.''
Under 10 CFR 19.13(b), licensees must make dose information
available to workers as shown in records maintained by the licensees.
The final rule revises 10 CFR 19.13(b) so that licensees must provide
an annual report to each individual monitored of the dose received in
that monitoring year if (1) the individual's occupational dose exceeds
1 millisievert (mSv) (100 millirem (mrem)) TEDE or 1 mSv (100 mrem) to
any individual organ or tissue; or (2) the individual requests his or
her annual dose report. However, the NRC will not require licensees to
provide unsolicited annual dose reports to those individuals whose
annual dose does not exceed these limits. The criterion of 1 mSv (100
mrem) applies to the whole body, to any individual organ or tissue, to
the lens of the eye, to the skin of the whole body, and to the skin of
the extremities. If the dose to any one of these exceeds the criterion
during a monitoring year, then the licensee must provide a dose report
to the individual for that year.
The criterion of 1 mSv (100 mrem) was selected because it meets the
Commission's regulatory objective to provide a significant reduction in
administrative and reporting burdens on licensees. In addition, it is
consistent with the occupational dose threshold for requiring
instruction to workers under 10 CFR 19.12, ``Instruction to Workers.''
As discussed in the Supplementary Information to the proposed rule,
recent occupational radiation exposure data submitted to the NRC under
10 CFR 20.2206, ``Reports of Individual Monitoring,'' indicates that
about 80 percent of the individuals monitored annually received a TEDE
that did not exceed 1 mSv (100 mrem). Based upon this information, the
final rule will result in a significant reduction in administrative and
reporting burdens on licensees.
The final rule does not change the Commission's requirements in 10
CFR Part 20, ``Standards for Protection Against Radiation,'' for
monitoring, recordkeeping, or reporting to the Commission. Therefore,
the final rule will not affect the level of protection for either the
health and safety of workers and the public or for the environment.
Under the existing regulatory framework, the requirement to inform
individuals of their routine annual doses, when determined through the
results of individual monitoring and when such a report is provided to
the Commission, appears multiple times in the regulations. This
requirement appears in 10 CFR 19.13(d) through the reference to 10 CFR
20.2206, ``Reports of Individual Monitoring.'' It also appears in 10
CFR 20.2205 through the reference to 10 CFR 20.2206. To improve
regulatory efficiency, this final rule removes the reference to 10 CFR
20.2206 in 10 CFR 19.13(d) and 10 CFR 20.2205, and consolidates the
requirement to report annual dose to the individual into a single
requirement in 10 CFR 19.13(b).
The NRC will also revise NRC Form 3, ``Notice to Employees,'' to
instruct workers on how the licensee is to provide dose annually to
workers consistent with the final rule.
B. Definition of Total Effective Dose Equivalent (TEDE)
The second amendment revises the definition of TEDE in 10 CFR
20.1003 and 10 CFR 50.2. Under the final rule, TEDE means the sum of
the effective dose equivalent (for external exposures) and the
committed effective dose equivalent (for internal exposures). The
revised definition of TEDE will allow licensees to substitute
``effective dose equivalent (EDE)'' for ``deep-dose equivalent (DDE)''
for external exposures. Conforming changes are also made to 10 CFR
1201, ``Occupational Dose Limits for Adults.''
This revision will clarify and make the definition of TEDE
consistent with Commission policy, as discussed in Regulatory Issue
Summary (RIS) 2002-06, ``Evaluating Occupational Dose for Individuals
Exposed to NRC-Licensed Material and Medical X-Rays,'' dated April 16,
2002, and subsequently clarified in RIS 2003-04, ``Use of the Effective
Dose Equivalent in Place of the Deep Dose Equivalent in Dose
Assessments,'' dated February 13, 2003, and RIS 2004-01, ``Method for
Estimating Effective Dose Equivalent From External Radiation Sources
Using Two Dosimeters,'' dated February 17, 2004. This policy explains
that the EDE is the primary quantity in the definition of TEDE for
external exposures but that licensees are required to use the DDE in
place of the EDE when measuring dose from external exposure, unless the
EDE is determined by a dosimetry method approved by the NRC.
In addition, 10 CFR 20.1201, paragraph (c) will be revised to add
the requirement that when the external exposure is determined by
measurement with an external personal monitoring device, the DDE must
be used in place of the EDE, unless the EDE is determined by a
dosimetry method approved by the NRC. In many external exposure
monitoring situations, determining EDE from external exposures may not
be practicable. The added administrative burden associated with
determining EDE may not be warranted, or an applicable dosimetry method
for determining EDE may not exist. The revised wording to 10 CFR
[[Page 68045]]
20.1201(c) clarifies that licensees can still use DDE in place of EDE
for the external exposure in demonstrating compliance with the TEDE
dose limit, consistent with the existing regulatory framework; however,
the DDE must be for the part of the whole body receiving the highest
exposure.
The final rule will not affect the level of protection for either
the health and safety of workers and the public or for the environment
because the revised definition of TEDE does not decrease the ability to
determine dose.
The NRC will also revise NRC Form 4, ``Cumulative Occupational Dose
History,'' and NRC Form 5, ``Occupational Dose Record for a Monitoring
Period,'' so that the licensee can enter either the DDE or EDE in Field
11 which currently is labeled ``Deep Dose Equivalent (DDE).'' In
addition, the instruction sheets for completing both forms will be
revised to clarify the method to be used to fill in Field 11, ``Deep
Dose Equivalent (DDE).'' Until these forms are revised, licensees
should enter in Field 11 the EDE from external exposure if this dose is
assessed by means other than a single dosimeter worn by the exposed
individual. Otherwise, the DDE is to be entered.
C. Labeling Containers
The third amendment revises 10 CFR 20.1905 by adding an exemption
for containers holding licensed material (other than sealed sources
that are either specifically or generally licensed) within nuclear
power facilities licensed under 10 CFR Part 50, ``Domestic Licensing of
Production and Utilization Facilities,'' or 10 CFR Part 52, ``Early
Site Permits; Standard Design Certifications; and Combined Licenses for
Nuclear Power Plants,'' providing certain conditions are met. Licensees
of these facilities need not label containers holding licensed material
that are within an area posted under 10 CFR 20.1902, ``Posting
Requirements,'' if the containers are conspicuously marked (to indicate
that they may contain licensed material) commensurate with the
radiological hazard and are accessible only to individuals who have
sufficient instruction to minimize radiation exposure while handling or
working in the vicinity of the containers. However, the final rule does
require the containers to be appropriately labeled under the
requirements of 10 CFR 20.1904, ``Labeling Containers,'' before being
removed from the posted area.
Under the existing regulatory framework, some nuclear power reactor
licensees interpreted 10 CFR 20.1904 to mean that they had to label all
containers in a posted area, whether they contained licensed material
or not, because every container has the potential for internal
contamination. This conservative interpretation of the current
regulations put an undue burden on these licensees. Thus, the final
revision to 10 CFR 20.1905 requires containers to be conspicuously
marked commensurate with the radiological hazard. The final rule
exempts the licensee from providing detailed labeling information such
as the radionuclide or radionuclides present, an estimate of the
quantity of radioactivity, the date for which the activity is
estimated, radiation levels, types of materials, and mass enrichment as
required under 10 CFR 20.1905. One purpose of adding conspicuous
markings on the containers is to indicate the potential for generating
airborne contamination or high radiation dose rates if the containers
were opened or mishandled. For example, these containers could be
conspicuously marked by using a color-coding system to indicate high,
medium, or low levels of activity or hazard. Containers such as 55-
gallon steel drums holding contaminated gloves and booties could be
marked with a color that represents low levels of activity or low
potential for airborne contamination. At nuclear power facilities,
containers located within a posted area are accessible only to
individuals who have had instruction under 10 CFR 19.12 and who have
been assigned a radiation work permit to control their activities.
Consequently, workers will be instructed on the handling of marked
containers before workers are given access to these containers.
The container marking system under this rule will reduce licensee
administrative and information collection burdens, but serve the same
health and safety functions as the current labeling requirements.
Therefore, the final rule will not affect the level of protection for
either the health and safety of workers and the public or for the
environment.
D. Cumulative Occupational Radiation Dose
The fourth amendment removes the provision in 10 CFR 20.2104(a)(2)
that requires licensees to attempt to obtain the records of cumulative
occupational radiation dose for each worker requiring monitoring under
10 CFR 20.1502, ``Conditions Requiring Individual Monitoring of
External and Internal Occupational Dose.'' Since the revision to 10 CFR
part 20 (56 FR 23391; May 21, 1991), cumulative lifetime dose is no
longer used in Part 20, except for cases involving planned special
exposures. That revision made it unnecessary for licensees to attempt
to obtain lifetime exposures for workers who are not participating in a
planned special exposure program. This issue was discussed further in
the Supplementary Information to the proposed rule (71 FR 55382;
September 22, 2006).
The final rule does not change the criterion under 10 CFR 20.1206,
``Planned Special Exposures,'' that requires licensees to ascertain the
exposure history of an individual's prior lifetime doses as required by
10 CFR 20.2104(b) before permitting an individual to participate in a
planned special exposure.
The Commission believes that the final amendment to 10 CFR
20.2104(a)(2) will result in a significant reduction in administrative
and information collection burdens on licensees. The final rule will
not affect the level of protection for either the health and safety of
workers and the public or for the environment, because the requirements
to determine an individual's occupational radiation dose received
during the current year or cumulative radiation dose prior to
permitting a planned special exposure have not been amended.
In 10 CFR 20.2104, paragraphs (c) and (d) will also be revised to
correct the omission of a reference to paragraph (b) in this section
regarding planned special exposures. Paragraph (b) requires that prior
to permitting an individual to participate in a planned special
exposure, the licensee must determine the internal and external doses
from all previous planned special exposures, and all doses in excess of
the limits (including doses received during accidents and emergencies)
received during the lifetime of the individual. This revision adds into
paragraphs (c) and (d) that licensees obtain complete records of the
worker's current and previously accumulated occupational dose in
complying with the provisions of 10 CFR 20.2104(b).
III. Summary and Analysis of Public Comments on the Proposed Rule
The NRC received 16 comment letters in response to the proposed
rule. The commenters included a number of individuals; industry
organizations; and power reactor, uranium recovery, and fuel facility
licensees. The majority of commenters supported NRC's approach. The
significant comments discussed below are arranged by subject. No
changes to the proposed rule language were made as a result of the
comment letters.
[[Page 68046]]
A. Annual Dose Report to Workers
Ten commenters specifically addressed this issue. All agreed with
the concept that there should be a defined dose threshold above which
licensees are required to provide an annual dose report to monitored
individuals. However, some took issue with the threshold proposed by
the NRC.
Comment. Two commenters stated that in order to provide comfort or
build trust, more employees are given dosimeters than necessary, and
that the effort to provide dosimetry to individuals should not be
complicated by a need to provide annual dose reports.
Response. The Commission's requirements on when to provide
dosimetry to a worker are separate from the requirements to provide
annual dose reports to workers. As explained in the Supplementary
Information accompanying the proposed rule, the NRC agrees that many
individuals required to be monitored receive very low doses but that,
under the current regulations, employers still had to generate and
provide reports of doses far below the regulatory limits in 10 CFR
20.1201(a).
Comment. One commenter said that there should be a reporting
requirement at the termination of employment or if the employee
develops a medical condition which could affect the employee's ability
to receive occupational exposure because individuals seeking new
employment need to be notified of their dose so that they can inform
their new employer.
Response. 10 CFR 19.13(e) currently requires that a licensee
provide at the request of a worker who is terminating employment with
the licensee, a written report of the radiation dose received by that
worker from the operations of the licensee during the current year or
fraction thereof. Exposures received as part of medical procedures are
not reported to the worker as part of the occupational exposure
received at a licensed facility. In the case of a medical condition
which could affect the worker's ability to receive occupational
exposure, it is the worker's responsibility to notify the licensee of
any condition that may interfere with the worker's duties. One example
is a woman declaring her pregnancy in order to be exposed to a reduced
dose level during the pregnancy. Therefore, the commenter's concerns
are addressed by the current regulations.
Comment. One commenter believed that the criteria for reporting
annual dose should be based on a percentage of the applicable limits to
preserve the graded approach to controlling exposure that the NRC
promotes in risk informed regulations, and recommended that licensees
should not be required to report occupational doses to workers when
their annual dose is less than 10 percent of the applicable dose
limits.
Response. The NRC disagrees with basing the criteria on a
percentage of the applicable limits. As explained in the Supplementary
Information accompanying the proposed rule, the approach used is
simpler because there is one reporting threshold instead of three
(i.e., the whole body, lens of the eye, and skin of the whole body or
skin of any extremity) and results in the same reduction in burden.
Comment. One commenter said that it is not clear why the NRC
selected 1 mSv (100 mrem) to be identical with the criterion for
requiring instruction to workers under 10 CFR 19.12. This commenter saw
no advantage in using the same criterion for notification and
instruction. This commenter also took issue with the NRC's position in
the Supplementary Information to the proposed rule that raising the
threshold from the proposed value of 1 mSv (100 mrem) would not
significantly reduce administrative and information collection burdens
on licensees. Another commenter believed it to be more logical to use 5
mSv (500 mrem) which is the threshold for requiring individual
monitoring of external dose.
Response. The NRC disagrees with these commenters. An analysis of
the occupational radiation exposure data in NUREG-0713, Volume 26,
(``Occupational Radiation Exposure at Commercial Nuclear Power Reactors
and Other Facilities 2004'' December 2005), indicates that about 80
percent (i.e., 94,534 individuals) of the 122,322 monitored individuals
received a TEDE that did not exceed 1 mSv (100 mrem). Furthermore,
61,725 of the monitored individuals received no measurable exposure.
Therefore, the threshold of 1 mSv (100 mrem) meets the Commission's
regulatory objective of providing a significant reduction in
administrative and reporting burden on licensees without adversely
impacting public health and safety. The analysis also indicates that
raising the threshold from 1 mSv (100 mrem) to 5 mSv (500 mrem) would
not further reduce significantly administrative and reporting burdens
on licensees.
Comment. A commenter objected to using a threshold of 1 mSv (100
mrem) for providing annual dose reports to workers because it results
in different requirements for a facility where individuals are
monitored and for a facility where individuals are not monitored. The
commenter believed that the rule provides a strong incentive for a
licensee to cease monitoring workers who might exceed 1 mSv (100 mrem)
in a year but are unlikely to exceed 5 mSv (500 mrem), the level of
exposure for which licensees are required to provide individual
monitoring of external occupational dose under 10 CFR 20.1502.
Response. The NRC disagrees with the commenter's assertion that the
threshold for reporting results in different requirements for licensed
facilities. The Commission's requirements for recordkeeping and
reporting of dose depend only on the licensee's decision to provide or
to not provide individual monitoring. The NRC also disagrees with the
commenter's assertion that the rule provides incentive for a licensee
to cease monitoring workers who might exceed 1 mSv (100 mrem) in a year
but are unlikely to exceed 5 mSv (500 mrem). The NRC believes that
licensees will choose to continue to provide monitoring to these
individuals for operational convenience because this practice helps
alleviate worker concerns of a possible significant exposure.
Comment. One commenter recommended allowing licensees to choose a
reporting criteria that is either the proposed requirement of 1 mSv
(100 mrem) or some optimal intermediate administrative threshold that
best relates to the licensee's conditions and practices.
Response. The NRC finds it unacceptable to allow licensees to
select the threshold value because it will result in a nonuniform
approach to providing reports to individuals.
Comment. One commenter recommended that both the reporting
requirements and the monitoring requirements use the same dose criteria
so as to not compromise programs for using dosimeters to confirm
compliance. This commenter also stated that 1 mSv (100 mrem) per year
is below the detection limit for thermoluminescence detectors that are
used for dosimeter wear periods that are less than a month.
Response. The NRC disagrees with using the same dose criteria
because the requirements for monitoring, recordkeeping, and reporting
address different aspects of the licensee's operations. The
Commission's requirements for recordkeeping and reporting of dose
depend only on the licensee's decision to provide or to not provide
individual monitoring.
Regarding the commenter's concern that 1 mSv (100 mrem) per year is
below the detection limit for
[[Page 68047]]
thermoluminescence detectors, the reporting requirements reflect
entries on NRC Form 5, which is the form currently used by licensees to
obtain the annual dose information that is reported to the workers.
Where monitoring was provided but the dose was not measurable, the
licensee can enter ``ND'' for ``Not Detectable'' on NRC Form 5.
Comment. Two commenters stated that the final rule language needs
to explicitly state that the reporting threshold applies to the whole
body, to the lens of the eye, to the skin of the whole body, and the
skin of the extremities.
Response. The NRC believes that the final rule language in 10 CFR
19.13(b) requires no further clarification. Requiring licensees to
provide an annual report to each individual when the individual's
occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to
any individual organ or tissue is inclusive of the dose to any part of
the body. If any dose value as reported on NRC Form 5 exceeds 1 mSv
(100 mrem), then an annual dose report must be provided to the
monitored individual. In addition, the revision to the reporting
requirements in 10 CFR 19.13(b) does not change the methods for
calculating doses to an individual.
Comment. One commenter stated that the Commission should consider a
two-tiered threshold: (1) 100 mrem for whole body and lens of the eye,
and (2) 1,000 mrem for extremities/organ, because there is a 10-fold
difference in the dose limits involved. The commenter also believed
that this approach would result in major administrative savings for
medical and research workers.
Response. The NRC disagrees with this comment. Several approaches
were evaluated for establishing a threshold value above which licensees
are required to provide an annual dose report to a monitored
individual. The approach selected for the final rule has the merit of
simplicity while also achieving the intended aim of reducing
unnecessary regulatory burden. The regulatory analysis conducted for
the final rule (Section X, below) shows that the 1 mSv (100 mrem)
annual reporting threshold by itself results in a significant burden
reduction for licensees as a whole.
B. Definition of Total Effective Dose Equivalent (TEDE)
Five commenters specifically addressed this issue. Most of these
commenters agreed with the proposed revision to the definition of TEDE
in 10 CFR 20.1003 and 10 CFR 50.2.
Comment. One commenter stated that the NRC has no basis to approve
dosimetry methods for determining the effective dose equivalent and
recommended allowing use of the effective dose equivalent when the
methodology is in accordance with a nationally recognized standard or
the radiation control agency with jurisdiction.
Response. The NRC disagrees that there is no basis to approve
dosimetry methods, and has published guidance on acceptable dosimetry
methods in RIS 2004-01, ``Method for Estimating Effective Dose
Equivalent From External Radiation Sources Using Two Dosimeters,'' RIS
2003-04, ``Use of the Effective Dose Equivalent in Place of the Deep
Dose Equivalent in Dose Assessments,'' and RIS 2002-06, ``Evaluating
Occupational Dose for Individuals Exposed to NRC-Licensed Material and
Medical X-Rays.'' Further guidance will be provided, as warranted, when
additional methods are determined acceptable by the NRC.
Comment. One commenter said that the Supplementary Information to
the proposed rule did not address how the change to the definition of
TEDE is consistent with the recommendations of the International
Commission on Radiological Protection (ICRP) and the National Council
on Radiation Protection and Measurements (NCRP).
Response. Total Effective Dose Equivalent (TEDE) in 10 CFR Part 20
is defined as the sum of two dosimetrically different quantities: The
deep-dose equivalent (DDE) for external exposure and the effective dose
equivalent (EDE) for internal exposure. This approach is not consistent
with the basic radiation protection premise that risk is directly
proportional to dose. The DDE is not, in many cases, proportional to
risk and is often a poor indicator of the risk arising from radiation
exposure. This approach of using mixed quantities to define the TEDE is
also not consistent with the recommendations of national and
international advisory groups such as the NCRP and the ICRP. These
groups quantify the total dose by adding the EDEs for both internal and
external exposures. The use of mixed quantities has caused significant
difficulties to NRC licensees, and has led the Commission to permit
substitution of EDE in place of DDE when calculating the TEDE, provided
the dose from external exposure is not based on measurements using
personnel dosimetry. This provision allows for the fact that the EDE
cannot be measured in the field, and when measurements are necessary as
the basis for quantifying the dose from external exposures, the DDE may
be used as a surrogate quantity that was defined in such a manner that
its magnitude provides a conservative numerical estimate for the EDE.
The final redefinition of TEDE implements this policy formally, a
policy that is now in effect and is being used by NRC licensees.
Comment. One commenter stated that NRC Forms 4 and 5 need to be
revised because of the change to the definition of TEDE, and that the
NRC provide options in guidance for reporting EDE versus DDE and for
making appropriate calculations of the total organ dose equivalent and
TEDE.
Response. The NRC agrees with the comment. NRC Forms 4 and 5 will
be revised to reflect the changes to the definition of TEDE. In
addition, the instruction sheets for completing both forms will be
revised to clarify the method to be used to fill in Field 11, ``Deep
Dose Equivalent (DDE).'' Guidance for estimating the EDE and DDE is
provided in numerous NRC guidance documents.
C. Labeling Containers
Four commenters specifically addressed this issue. All of the
commenters disagreed with the approach taken by the NRC in the proposed
rule to limit the exemption to labeling requirements under 10 CFR
20.1905 to nuclear power reactor licensees, and believed that
additional categories of licensees should be granted the exemption to
labeling requirements for containers holding licensed material.
Comment. Two commenters stated that the container labeling
exemption should be granted to university and medical licensees. One
commenter indicated that power reactors have more types of
radioactivity and a great range of activity because of the mixtures of
fission and activation products, while university and medical areas
have pure and well-defined materials used under controlled conditions,
mostly employing low quantities of materials with short half lives. The
commenter indicated that therefore a dichotomy in the rules for nuclear
power plants and other licensees is unjustified. The other commenter
stated that the current exemptions in 10 CFR 20.1905 pertain to
labeling of containers with applicability to all licensees, and that
limiting this exemption to nuclear power facilities for the reasons
stated in the Supplementary Information to the proposed rule
demonstrates an incomplete understanding of the safety measures in
large medical and research facilities. The commenter stated if an undue
burden has been placed on the nuclear power industry because of an
overly conservative interpretation of the rules, the NRC should
specifically be
[[Page 68048]]
tasked to broaden that interpretation, not exempt a single licensee
category from a rule applicable to all other licensees.
Response. The NRC disagrees with granting the exemption from
labeling requirements to university and medical licensees. The burden
imposed on nuclear power plant licensees by the current regulation is
due to an overly conservative interpretation because of the existence
of a large number of structures in a protected area of a nuclear power
plant that may be inappropriately considered to be containers holding
licensed material, such as cable trays, and containers holding
contaminated tools or protective clothing. This situation does not
exist at other types of licensed facilities. In addition, although the
NRC agrees with the commenter that university and medical licensees
implement stringent radiation control programs, the level of redundancy
in protective measures in these programs is not as extensive as that
found at nuclear power plants. The NRC believes that removing one such
measure at nuclear power plants, i.e., labeling containers holding
licensed material, will be compensated for by the redundancy in their
radiation protection programs. Such extensive redundancy is not
normally found in university and medical radiation protection programs.
Comment. Two commenters recommended that the container labeling
exemption be granted to all licensees under 10 CFR part 70, ``Domestic
Licensing of Special Nuclear Material.'' One of these commenters
believed that all Part 70 licensees now have this provision in their
licenses. This commenter also noted that a Part 70 licensee's variance
in radiological hazards is comparable to that of a Part 50 or Part 52
license.
Response. The NRC disagrees that there is a need to extend the
exemption from labeling requirements to include Part 70 licensees.
Currently, only Part 70 licensees subject to Subpart H requirements
have a license condition that provides the exemption from the labeling
requirements of this rule. The Commission has determined that for the
remainder of the Part 70 licensees, this license condition is not
required. The existing labeling requirements are not a burden to these
licensees because they handle few containers holding radioactive
material.
Comment. One commenter suggested that the exemption be expanded to
include containers removed from a posted area as long as the container
is under continuous direct or electronic surveillance while in transit
between one posted area to another.
Response. The exemption from labeling requirements suggested by the
commenter is already provided in 10 CFR 20.1905(c). That regulation
specifies that a licensee is not required to label containers attended
by an individual who takes the precautions necessary to prevent the
exposure of individuals in excess of the limits established by 10 CFR
Part 20.
D. Cumulative Occupational Radiation Dose
Ten commenters addressed this issue. Most of the commenters agreed
with removing the provision in 10 CFR 20.2104(a)(2) that requires
licensees to attempt to obtain the records of cumulative occupational
radiation dose for each worker requiring monitoring under 10 CFR
20.1502.
Comment. Two commenters suggested that the cost savings to
licensees from the revision to 10 CFR 20.2104 have been underestimated.
Specifically, these commenters recommended that the NRC consider the
savings to those licensees who will no longer have to provide prior
dose records to a requesting licensee, stating that the savings of not
having to provide prior dose records is $20 per new employee. This
estimate is based on an assumption of a savings of $10 per request and
on the fact that two licensees would be requested to provide the
records per new employee.
Response. The NRC agrees with the comments and the regulatory
analysis for the final rule found in Section X has been revised to use
the suggested values.
Comment. One commenter expressed a concern that it is essential for
the licensee to obtain current year dose records.
Response. The NRC agrees with the need for a licensee to determine
and record the dose for an individual during the current year. The
final rule does not revise the requirements in 10 CFR 20.2104(a) that
require a licensee to determine the occupational radiation dose
received by an individual during the current year. The final rule
removes only the requirement that licensees attempt to obtain
cumulative exposure records for workers, i.e., exposure records for
previous years, unless these individuals are being authorized to
receive a planned special exposure.
Comment. One commenter suggested that an additional revision be
made to 10 CFR 19.13 to remove the language in paragraph (a) regarding
using an individual's social security number as an appropriate
identifier for reports. This commenter was concerned about the risk of
identity theft.
Response. Based on recent Office of Management and Budget guidance,
Federal agencies, including the NRC, are reviewing their uses of Social
Security Numbers (SSNs) with the goal of eliminating unnecessary uses
of SSNs. However, revision of 10 CFR 19.13(a) to remove the language
specific to using the individual's social security number as an
identifier is outside the scope of this rulemaking.
Comment. One commenter believed that removing the requirement in 10
CFR 20.2104(a)(2) to attempt to obtain the records of cumulative
occupational radiation dose would eliminate lifetime dose records and
the ability to do any retrospective, low dose occupational risk
assessments.
Response. As explained in the Supplementary Information
accompanying the proposed rule, occupational exposures were initially
restricted by the cumulative lifetime dose received and, under certain
circumstances, an individual could receive as much as 0.12 Sv (12 rems)
in a year. However, following revision to 10 CFR Part 20 (56 FR 23391;
May 21, 1991), cumulative lifetime dose is no longer used in the
Commission's regulations to restrict occupational exposures. The
reduced occupational dose limit of 0.05 Sv (5 rems) per year in the
current 10 CFR 20.1201(a)(1)(i) essentially accomplishes the same goal
as the previous dose limit of 0.03 Sv (3 rems) per calendar quarter
constrained by the then age-dependent, cumulative lifetime dose limit.
(The goal is an average cumulative dose rate of 0.05 Sv (5 rems) per
year to the individual.) Therefore, it is no longer necessary for
licensees to obtain records of cumulative occupational dose. However,
10 CFR Part 20 still requires licensees to maintain records of
individual monitoring results and to submit to the NRC an annual report
of the results of individual monitoring. The ability to do a
retrospective dose assessment is not affected by this final rule. The
revision to 10 CFR 20.2104(a)(2) does not change the Commission's
requirements for monitoring individuals or for maintaining records of
doses received by individuals at licensed facilities. Thus, the dose
records for individuals whose exposure histories span more than one
licensed facility will still be available for risk assessments.
Comment. One commenter stated that removing the requirement in 10
CFR 20.2104(a)(2) will not reduce future burden on licensees because if
the NRC implements the proposed International
[[Page 68049]]
Commission on Radiological Protection (ICRP) recommendation on dose
limits averaged over several years, then licensees will need to
reconstruct a worker's prior dose records.
Response. A change in this area would not affect the ability of
licensees to implement dose averaging if the Commission were to decide
to adopt this practice in the future. The revision does not remove the
requirement to record and report the doses received by monitored
workers, rather, it simply removes the requirements for each licensee
to compile the exposure history of each worker as recorded on FORM 5s
unless the worker is being authorized to receive a planned special
exposure. Should another purpose develop (such as dose averaging) that
would justify such data compilation, it would be as easy to do as for a
planned special exposure, because the records would still be available.
Comment. One commenter stated that the rule should be expanded to
not require a licensee to obtain a worker's dose records prior to
permitting the worker to participate in a planned special exposure, but
to require the worker to retrieve this data. The commenter believed
that this would alleviate an administrative burden on the licensee.
Response. This comment is outside the scope of this rulemaking. The
final rule does not address the methods used to obtain a worker's dose
history when that dose history is required prior to permitting the
worker to participate in a planned special exposure. The final rule
only removes the requirement for a licensee to obtain the records of
cumulative occupational radiation dose except when authorizing a
planned special exposure.
IV. Section-by-Section Analysis of Final Revisions
This final rule amends 10 CFR 19.13, 20.1003, 20.1201, 20.1905,
20.2104, 20.2205, and 50.2.
Section 19.13--Notifications and Reports to Individuals.
Paragraph (b) is revised to require a licensee to provide an annual
dose report to an individual when the individual's occupational dose
exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual
organ or tissue, or when the individual requests a report of the
individual's annual dose, and that all dose records shall be made
available to workers onsite.
In order to consolidate the requirement to report annual dose to
the individual into a single requirement in 10 CFR 19.13(b), paragraph
(d) is revised to remove the reference to 10 CFR 20.2206.
Section 20.1003--Definitions.
In 10 CFR 20.1003, the definition of Total Effective Dose
Equivalent (TEDE) is revised to state that TEDE is the sum of the
effective dose equivalent (for external exposures) and the committed
effective dose equivalent (for internal exposures).
Section 20.1201--Occupational Dose Limits for Adults.
Paragraph (c) is revised to add the requirement that when the
external exposure is determined by measurement with an external
personal monitoring device, the deep-dose equivalent must be used in
place of the effective dose equivalent, unless the effective dose
equivalent is determined by a dosimetry method approved by the NRC.
Section 20.1905--Exemptions to Labeling Requirements.
A new paragraph (g) is added to 10 CFR 20.1905 to provide an
exemption for containers holding licensed material (other than sealed
sources that are either specifically or generally licensed) that are in
an area posted under the requirements of 10 CFR 20.1902 at a nuclear
power facility. The final rule does not require the licensee to label
the container according to 10 CFR 20.1904 if it is conspicuously marked
(such as by color coding) commensurate with the radiological hazard and
accessible only to individuals who have sufficient instruction to
minimize radiation exposure while handling or working in the vicinity
of the containers. The final rule also requires that the container must
be appropriately labeled as required by 10 CFR 20.1904 before being
removed from the posted area. This exemption to the labeling
requirements for containers holding licensed material does not apply to
non-power reactor and materials licensees, or for sealed sources.
Section 20.2104--Determination of Prior Occupational Dose.
Paragraph (a)(2) is removed to delete the requirement that
licensees attempt to obtain the records of cumulative occupational
radiation dose. The introductory text of paragraph (a) and paragraph
(a)(1) are combined and designated as paragraph (a). Paragraphs (c) and
(d) are also revised to add a reference to paragraph (b) in this
section regarding planned special exposures.
Section 20.2205--Reports to Individuals of Exceeding Dose Limits.
Section 20.2205 is revised to remove the reference to 10 CFR
20.2206, in order to consolidate the requirement to report annual dose
to the individual into a single requirement in 10 CFR 19.13(b).
Section 50.2--Definitions.
In 10 CFR 20.1003, the definition of Total Effective Dose
Equivalent (TEDE) is revised to state that TEDE is the sum of the
effective dose equivalent (for external exposures) and the committed
effective dose equivalent (for internal exposures).
V. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs,'' approved by the Commission on June 30,
1997, and published in the Federal Register (62 FR 46517; September 3,
1997), this rule is a matter of compatibility between NRC and the
Agreement States, thereby providing consistency among the Agreement
States and the NRC's requirements. The NRC analyzed the rule in
accordance with the procedure established in Part III, ``Categorization
Process for NRC Program Elements,'' of Handbook 5.9 to Management
Directive 5.9, ``Adequacy and Compatibility of Agreement State
Programs'' (which may be viewed at http://nrc-stp.ornl.gov/). The NRC
has determined that the compatibility categories for the sections
amended in this rule are the same as for the sections in the existing
regulations, except for the new exemption (g) added to 10 CFR 20.1905.
The revisions to 10 CFR 19.13 and 20.2205 are classified as
Compatibility Category C. A Compatibility Category C designation means
the Agreement State should adopt the essential objectives of the
requirement to avoid conflicts, duplications, or gaps.
The revisions to 10 CFR 20.1003 and 20.1201(c) are classified as
Compatibility Category A. A Compatibility Category A designation means
the requirement is a basic radiation protection standard or related
definition, sign, label, or term necessary for a common understanding
of radiation protection principles. Agreement State requirements
designated Compatibility Category A should be essentially identical to
NRC requirements.
The new exemption (g) added to 10 CFR 20.1905 is classified as
Compatibility Category NRC. A Compatibility Category NRC designation
means the Agreement State should not
[[Page 68050]]
adopt the requirement for purposes of compatibility. These are NRC
program elements that address regulatory items that cannot be
relinquished to Agreement States under the Atomic Energy Act or
provisions of the regulations in title 10 of the CFR.
The revision to 10 CFR 20.2104(a) is classified as Compatibility
Category D. A Compatibility Category D designation means the Agreement
State is not required to adopt the requirement for compatibility.
VI. Availability of Documents
The NRC is making the documents identified below available to
interested persons through one or more of the following methods.
Public Document Room (PDR). The NRC Public Document Room is located
at 11555 Rockville Pike, Rockville, Maryland.
NRC's Agency-wide Documents Access and Management System (ADAMS).
The NRC's PARS Library is located at www.nrc.gov/reading-rm/adams.html.
The NRC staff contact (NRC Staff). Stewart Schneider, U.S. Nuclear
Regulatory Commission, Mail Stop O-12D3, Washington, DC 20555-0001;
telephone (301) 415-4123; [email protected].
------------------------------------------------------------------------
Document PDR ADAMS NRC staff
------------------------------------------------------------------------
Final Rulemaking.............. X X X
Public Comments on Proposed X X X
Rule.........................
Proposed Rulemaking (71 FR X X X
55382; September 22, 2006)...
NRC Form 3.................... X X X
NRC Form 4.................... X X X
NRC Form 5.................... X X X
RIS 2002-06................... X X X
RIS 2003-04................... X X X
RIS 2004-01................... X X X
NUREG-0713, Vol. 26........... X X
NUREG-1350, Vol. 17........... X X
NUREG/BR-0184................. X X
NUREG/BR-0058, Rev. 4......... X X
Standards for Protection X X
Against Radiation: Final Rule
(56 FR 23391; May 21, 1991)..
NRC Strategic Plan, Fiscal X X X
Year 2000-Fiscal Year 2005...
------------------------------------------------------------------------
Copies of NUREGs may be purchased from The Superintendent of
Documents, U.S. Government Printing Office, Mail Stop SSOP, Washington,
DC 20402-0001; Internet: bookstore.gpo.gov; (202) 512-1800. Copies are
also available from the National Technical Information Service,
Springfield, VA 22161-0002; http://www.ntis.gov; 1-800-553-6847 or,
locally, (703) 605-6000. Some publications in the NUREG series are
included in the document collections in the Electronic Reading Room on
NRC's Web site at http://www.nrc.gov/reading-rm.html.
VII. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995, Pub.
L. 104-113, requires that Federal agencies use technical standards that
are developed or adopted by voluntary consensus standards bodies unless
using such a standard is inconsistent with applicable law or is
otherwise impractical. In this final rule, the NRC is revising
requirements for the reporting of annual dose to workers, the
definition of Total Effective Dose Equivalent (TEDE), the labeling of
certain containers holding licensed material, and the determination of
cumulative occupational radiation dose. This regulatory action does not
constitute the establishment of a standard that contains generally
applicable requirements.
VIII. Environmental Impact: Categorical Exclusion
The NRC has determined that the amendments to 10 CFR parts 19, 20,
and 50 are the types of actions described in categorical exclusion 10
CFR 51.22(c). Therefore, neither an environmental impact statement nor
an environmental assessment has been prepared for this regulatory
action. Specifically, the revision to 10 CFR 19.13(b) to limit the
routine reporting of annual doses to workers comes under the
categorical exclusion in 10 CFR 51.22(c)(1), which covers all revisions
to 10 CFR part 19. The amendments to the definition of TEDE in 10 CFR
20.1003 and 10 CFR 50.2 and to 10 CFR 20.1201(c) to add the requirement
that the effective dose equivalent be determined by a dosimetry method
approved by the NRC come under the categorical exclusion in 10 CFR
51.22(c)(2) because these revisions are of a minor nature and do not
substantially modify existing regulations. For the amendments to 10 CFR
20.1905 to revise the requirements for labeling containers and to 10
CFR 20.2104 to remove the requirement to obtain lifetime exposure
records, these revisions involve recordkeeping requirements and thus
come under the categorical exclusion in 10 CFR 51.22(c)(3)(ii).
Finally, because the amendment to 10 CFR 20.2205 involves a reporting
requirement, this revision comes under the categorical exclusion in 10
CFR 51.22(c)(3)(iii).
IX. Paperwork Reduction Act Statement
This final rule amends information collection requirements
contained in 10 CFR Parts 19, 20, and 50, and NRC Form 4 that are
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). These requirements were approved by the Office of Management and
Budget, approval numbers 3150-0044, 3150-0014, 3150-0011, and 3150-
0005. The changes to 10 CFR Parts 19, 20, and 50, and NRC Form 4 do not
contain a new or amended information collection requirements. Existing
requirements were approved by the Office of Management and Budget,
approval number(s) 3150-0044, 3150-0014, 3150-0011, and 3150-0005.
Because the rule will reduce the burden for existing information
collection requirements, the public burden for the information
collections in 10 CFR parts 19 and NRC Form 4 is expected to be
decreased by 235 and 44 hours per licensee, respectively. This
reduction includes the time required for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed and completing and reviewing the information collection. Send
comments on any aspect of these information collections, including
suggestions for further reducing the burden, to the Records and FOIA/
Privacy Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission,
Washington,
[[Page 68051]]
DC 20555-0001, or by Internet electronic mail to [email protected];
and to the Desk Officer, Office of Information and Regulatory Affairs,
NEOB-10202, (3150-0044, 3150-0014, 3150-0011, and 3150-0005) Office of
Management and Budget, Washington, DC 20503.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.
X. Regulatory Analysis
The Commission has prepared a regulatory analysis on this final
rule and has included it in this Federal Register notice. The analysis
examines the costs and benefits of the alternatives considered by the
Commission. The Commission requested public comment on the draft
regulatory analysis for the proposed rule (71 FR 55382; September 22,
2006). Two comments were received on the draft regulatory analysis and
are discussed above in Section III. These comments were considered and
the regulatory analysis revised appropriately.
1. Statement of the Problem and Objective
The NRC has determined that the regulations in 10 CFR 19.13,
20.1003, 20.1201, 20.1905, 20.2104, and 50.2 impose an undue regulatory
burden on licensees. The final rule makes these regulations consistent
with current Commission policy and reduces administrative and
information collection burdens on NRC and Agreement State licensees.
The final rule amends certain requirements for notification of workers,
revises the definition of Total Effective Dose Equivalent (TEDE),
amends certain container labeling requirements, and removes the
requirement that licensees attempt to obtain the records of cumulative
occupational radiation dose for certain individuals. These revisions do
not affect the level of protection for either the health and safety of
workers and the public or for the environment.
2. Identification of Regulatory Alternatives
This regulatory analysis evaluates the savings and costs of two
regulatory alternatives. The following subsections describe these two
alternatives.
2.1 No-Action Alternative
The no-action alternative is the status quo had this rule not been
promulgated. Under that alternative, licensees would have been required
to: (1) Provide annual dose reports to all monitored individuals, (2)
determine the TEDE by summing the deep-dose equivalent (for external
exposures) and the committed effective dose equivalent (for external
doses), (3) use the current exemptions to labeling requirements for
containers holding licensed material, and (4) attempt to obtain the
records of lifetime occupational radiation dose for all individuals.
The no-action alternative is the baseline for analyzing the rule
alternative. The no-action alternative does not accomplish the stated
objective.
2.2 Rule Alternative
Under the rule alternative, the NRC is revising its regulations in
10 CFR parts 19, 20, and 50 for: (1) Reporting dose to workers, (2) the
definition of TEDE, (3) the labeling of certain containers holding
licensed material, and (4) the requirement that licensees attempt to
obtain the records of cumulative occupational radiation dose for all
individuals. This alternative makes the regulations consistent with
current Commission policy and reduces administrative and information
collection burdens on NRC and Agreement State licensees. Because this
action is being taken to ease burden, the rulemaking process is the
only regulatory option appropriate to make the changes effective.
3. Analysis of Values and Impacts
3.1 Identification of Affected Attributes
The attributes that the rule could affect were identified by using
the list of potential attributes provided in Chapter 5 of NUREG/BR-
0184, ``Regulatory Analysis Technical Evaluation Handbook'' (January
1997).
Industry Implementation. This attribute is affected by three of the
four principal revisions: The revisions to the requirements for the
annual dose reports to workers, the labeling of containers holding
licensed material, and the attempt to obtain the records of cumulative
occupational radiation dose for an individual. In implementing these
changes, licensees will incur the costs of revising procedures.
Industry Operation. This attribute is affected by three of the four
principal revisions. Licensees will realize savings by only having to
provide annual dose reports to individuals when their dose exceeds 1
mSv (100 mrem), by not having to label containers holding licensed
material (except sealed sources that are already labeled) in a posted
area in a nuclear power facility, and by not having to ascertain the
exposure history of an individual's prior lifetime doses except to
permit an individual to participate in a planned special exposure.
NRC Implementation. The NRC will incur costs to make minor
revisions to NRC Form 3, ``Notice to Employees,'' to account for the
revisions to the reporting of annual dose to workers. In addition, the
NRC will incur costs to make minor revisions to NRC Form 4,
``Cumulative Occupational Dose History,'' and NRC Form 5,
``Occupational Dose Record for a Monitoring Period,'' and their
instructions, to account for the revision to the definition of TEDE.
Regulatory Efficiency. All four of the principal revisions will
enhance regulatory efficiency. The revisions are intended to reduce
administrative and information collection burdens on NRC and Agreement
State licensees without affecting the level of protection for either
the health and safety of workers and the public or for the environment.
3.2 Methodology
The incremental savings and costs of the regulatory action are
analyzed relative to the baseline described in Section 2.1 of this
regulatory analysis. The savings come from any desirable changes in the
affected attributes, while the costs come from any undesirable changes
in the affected attributes.
Under Office of Management and Budget guidance and NUREG/BR-0058,
``Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory
Commission,'' Revision 4 (September 2004), the results of the analysis
are presented using a discounted flow of funds at a 3 and 7 percent
real discount rate.
Under 10 CFR 20.2206, seven categories of NRC licensees are
required to submit to the NRC annual radiation exposure reports for
monitored individuals: Commercial nuclear power reactors; industrial
radiographers; fuel processors (including uranium enrichment),
fabricators and reprocessors; manufacturers and distributors of
byproduct material; independent spent fuel storage installations;
facilities for land disposal of low-level waste; and geologic
repositories for high-level waste. (No NRC licensees are currently
involved in operating low-level waste disposal facilities or geologic
repositories for high-level waste.) In addition, 10 CFR 20.2206(b)
requires that licensees submit annual reports using NRC Form
[[Page 68052]]
5 or electronic media containing all the information required by NRC
Form 5. For the above licensees, the value-impact analysis uses the
occupational exposure data maintained in the NRC's Radiation Exposure
Information and Reporting System (REIRS) database (NUREG-0713, Volume
26, ``Occupational Radiation Exposure at Commercial Nuclear Power
Reactors and Other Facilities 2004'' (December 2005)). While more
recent data has been issued, the values have not changed significantly
from those used in the regulatory analysis for the proposed rule. To
simplify the analysis, the seven categories of licensees are
consolidated into two groups. The first group contains only commercial
nuclear power reactor licensees (nuclear power reactor licensees) and
the second group contains all of the other licensee categories listed
above (REIRS materials licensees).
The seven categories of licensees specified in 10 CFR 20.2206 do
not include all NRC licensees. Most NRC licensees (e.g., hospitals,
medical facilities, universities, radiological services, disposal) are
not required to submit annual radiation exposure reports for monitored
individuals. These licensees (non-REIRS materials licensees) constitute
the third group of licensees for whom a value-impact analysis was done.
This group contains both Agreement State and NRC licensees. For this
group of licensees, the NRC has no records of the number of monitored
individuals or the annual doses they received (except in the rare case
of an overexposure). Based on professional judgment, the NRC assumes
that 500,000 individuals are monitored annually by non-REIRS materials
licensees. In addition, it is assumed that about 70 percent of them
receive an annual dose that does not exceed 1 mSv (100 mrem). This
factor is derived from the data in NUREG-0713 for REIRS materials
licensees and is assumed to apply to non-REIRS materials licensees.
The following assumptions and data were used to assess the
incremental values and impacts associated with the regulatory action.
Based on NUREG-0713, the number of nuclear power reactor
licensees is 104 (NRC licensees only).
Based on NUREG-0713, the number of REIRS materials
licensees is 123 (NRC licensees only).
Based on NUREG-1350, Volume 17, ``NRC Information Digest:
2005-2006 Edition'' (July 2005), there are approximately 17,298
Agreement State licensees. While more recent data has been issued, the
values have not changed significantly from those used in the regulatory
analysis for the proposed rule.
The number of non-REIRS materials licensees (Agreement
State and NRC licensees) was estimated as follows. A review of the NRC
Licensing Tracking System database in October 2005 indicated that a
total of 4,517 materials licensees are administered by the NRC. While
more recent data has been issued, the values have not changed
significantly from those used in the regulatory analysis for the
proposed rule. Correcting for the 123 REIRS materials licensees in the
database and accounting for Agreement State licensees, the total number
of Agreement State and NRC licensees designated as non-REIRS materials
licensees is approximately 21,692 licensees (17,298 Agreement State
licensees + 4,517 NRC materials licensees-123 REIRS materials
licensees).
The number of NRC licensees designated as non-REIRS
materials licensees is 4,394 licensees (4,517 NRC materials licensees-
123 REIRS materials licensees).
Based on NUREG-0713, the number of individuals working for
all nuclear power reactor licensees is 110,290.
The average number of individuals working at each of the
104 nuclear power plants is estimated to be 1,060.
Based on NUREG-0713, the number of individuals working for
all REIRS materials licensees is 12,032.
Based on professional judgment, the NRC assumes that
500,000 individuals are monitored annually by non-REIRS materials
licensees (Agreement State and NRC licensees).
Based on NUREG-0713, 70 percent of the individuals
monitored by nuclear power reactor licensees receive an annual dose
that does not exceed 1 mSv (100 mrem).
Based on NUREG-0713, 80 percent of the individuals
monitored by REIRS materials licensees receive an annual dose that does
not exceed 1 mSv (100 mrem).
Based on NUREG-0713 and professional judgment, the NRC
assumes that 80 percent of the individuals monitored by non-REIRS
materials licensees receive an annual dose that does not exceed 1 mSv
(100 mrem).
The NRC estimates that procedural revisions will require
20 hours for each of the 104 nuclear power plants.
For REIRS and non-REIRS materials licensees, the time
needed to revise procedures ranges from 2 to 20 hours, depending on the
size of the facility. This analysis uses 10 hours as the average time
to revise procedures for these licensees.
For nuclear power reactor licensees, it is assumed that
the average life remaining for power reactor facilities is 49 years.
For 3 and 7 percent real discount rates, the analysis uses present
value multiplication factors of 25.50 and 13.77, respectively,
following the guidance in NUREG/BR-0184.
For REIRS and non-REIRS materials licensees, it is assumed
that the average life remaining for the facilities is 20 years. For 3
and 7 percent real discount rates, the analysis uses factors of 14.9
and 10.6, respectively, following the guidance in NUREG/BR-0184.
3.3 Analysis
3.3.1 Annual Dose Report to Workers
Nuclear power reactor licensees.
In implementing the regulatory action, nuclear power reactor
licensees will incur a one-time cost to revise procedures. The NRC
estimates it will take 20 hours to revise the procedures for each of
the 104 nuclear power plants. Assuming a staff rate of $105 per hour,
the one-time cost of implementing the regulatory action will be $2,100
per nuclear power plant (20 hours x $105/hour) and $220,000 for the
nuclear power industry (104 licensees x $2,100/licensee).
With respect to industry operation, there will be a savings from
not having to provide unsolicited annual dose reports (NRC Form 5) to
workers when their doses do not exceed 1 mSv (100 mrem). As discussed
in the regulatory analysis for the proposed rule (71 FR 55382;
September 22, 2006), the NRC estimated the annual savings to be $3,000
per nuclear power plant and $310,000 for the nuclear power industry
($3,000 x 104 licensees). For a flow of funds at a 3 percent real
discount rate, the estimated savings per nuclear power plant and for
the nuclear power industry are $77,000 ($3,000 x 25.50) and $8 million
($310,000 x 25.50), respectively. For a flow of funds at a 7 percent
real discount rate, the estimated savings per nuclear power plant and
for the nuclear power industry are $41,000 ($3,000 x 13.77) and $4.3
million ($310,000 x 13.77), respectively.
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. The NRC estimates it will
take 5 minutes (0.083 hour) for a licensee to prepare an annual dose
report for each worker. Using the 2004 data in NUREG-0713, it was
determined that about 80 percent of the monitored individuals had an
annual dose that did not exceed 1 mSv (100 mrem). It is further assumed
that
[[Page 68053]]
90 percent of this population will not request an annual dose report.
Assuming an average of 1,060 workers per nuclear power plant, the
annual burden reduction from implementing the regulatory action is
estimated to be 63 hours per nuclear power plant (1,060 workers x 0.083
hour x 0.8 x 0.9) and the total annual industry burden reduction is
6,600 hours (63 hours/licensee x 104 licensees).
REIRS materials licensees.
In implementing the regulatory action, REIRS materials licensees
will incur a one-time cost to revise procedures. The NRC estimates it
will take 10 hours to revise the procedures for each of the 123 REIRS
materials licensees. Assuming a staff rate of $105 per hour, the one-
time cost of implementing the regulatory action will be $1,050 per
licensee (10 hours x $105/hour) and $130,000 for all licensees in this
category (123 licensees x $1,050/licensee).
With respect to industry operation, using the 2004 data in NUREG-
0713, it was determined that 8,254 workers (about 70 percent of the
monitored individuals) had an annual dose that did not exceed 1 mSv
(100 mrem). Assuming these workers are equally distributed among the
123 licensees in this group, about 67 workers per licensee will not
receive an annual dose report. It is further assumed that 90 percent of
this population will not request an annual dose report (NRC Form 5).
The NRC estimates a savings of $10 per worker not receiving a dose
report. Thus, the estimated annual savings is $600 per licensee (67
workers/licensee x $10/worker x 0.9) and $74,000 for all licensees in
this category ($600/licensee x 123 licensees). For a flow of funds at a
3 percent real discount rate, the estimated savings per licensee and
for all licensees in this category are $9,000 ($600 x 14.9) and $1.1
million ($74,000 x 14.9), respectively. For a flow of funds at a 7
percent real discount rate, the estimated savings per licensee and for
all licensees in this category are $7,000 ($670 x 10.6) and $780,000
($74,000 x 10.6), respectively.
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. The NRC estimates it will
take 5 minutes (0.083 hour) for a licensee to prepare an annual dose
report for each worker. Assuming that 90 percent of the 67 workers per
licensee will not request a dose report, the annual burden reduction
from implementing the regulatory action is estimated to be 5 hours per
licensee (67 workers x 0.083 hour x 0.9) and 620 hours for all
licensees in this category (5 hours/licensee x 123 licensees).
Non-REIRS materials licensees.
In implementing the regulatory action, non-REIRS materials
licensees will incur a one-time cost to revise procedures. The NRC
estimates it will take 10 hours to revise the procedures for each of
the 21,692 non-REIRS materials licensees. Assuming a staff rate of $105
per hour, the one-time cost of implementing the regulatory action will
be $1,050 per licensee (10 hours x $105/hour) and $23 million for all
licensees in this category (21,692 licensees x $1,050/licensee).
With respect to industry operation, the NRC assumes 500,000
monitored workers, 21,692 non-REIRS licensees, 23 workers per licensee,
and a savings of $10 for each worker who does not receive a dose
report. In addition, the previously defined factor of 70 percent for
REIRS materials licensees is used to estimate the fraction of workers
who will not receive an annual dose report (NRC Form 5). Thus, 16
workers per licensee are assumed to not receive an annual dose report.
It is further assumed that 90 percent of this population will not
request an annual dose report. The estimated annual savings is $140 per
licensee (16 workers/licensee x $10/worker x 0.9) and $3 million for
all licensees in this category ($140/licensee x 21,692 licensees). For
a flow of funds at a 3 percent real discount rate, the estimated
savings per licensee and for all licensees in this category are $2,000
($140 x 14.9) and $45 million ($3 million x 14.9), respectively. For a
flow of funds at a 7 percent real discount rate, the estimated savings
per licensee and for all licensees in this category are $1,500 ($140 x
10.6) and $32 million ($3 million x 10.6), respectively.
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. The NRC estimates it will
take 5 minutes (0.083 hour) for a licensee to prepare an annual dose
report for each worker. Assuming that 90 percent of the 16 workers per
licensee will not request a dose report, the annual burden reduction
from implementing the regulatory action is estimated to be 1.2 hours
per licensee (16 workers x 0.083 hour x 0.9) and 26,000 hours for all
licensees in this category (1.2 hours/licensee x 21,692 licensees). For
NRC licensees only, the total annual burden reduction is estimated to
be 5,300 hours (1.2 hours/licensee x 4,394 NRC licensees).
3.3.2 Definition of Total Effective Dose Equivalent (TEDE)
The costs and savings associated with the revised definition of
TEDE are minimal. The revision clarifies that the TEDE is defined in
terms of the effective dose equivalent (for external exposures) and the
committed effective dose equivalent (for internal exposures). This
revision eliminates the need for licensees to repeatedly request
guidance from the NRC and, in some cases, to request a license
amendment to clarify the definition.
3.3.3 Labeling Containers
The revision to 10 CFR 20.1905, ``Exemptions to labeling
requirements,'' applies only to nuclear power reactor licensees. These
licensees will incur one-time implementation costs to revise
procedures. The NRC estimates it will take 20 hours to revise the
procedures for each of the 104 nuclear power plants. Assuming a staff
rate of $105 per hour, the one-time cost of implementing the regulatory
action will be $2,100 per licensee (20 hours x $105/hour) and $220,000
for the nuclear power industry (104 licensees x $2,100/licensee).
With respect to industry operation, as discussed in the regulatory
analysis for the proposed rule (71 FR 55382; September 22, 2006), the
NRC estimated an annual savings of $30,000 per nuclear power plant from
using the exemption to labeling requirements for containers holding
licensed material within a posted area. For the entire nuclear power
industry, the NRC estimates a savings of $3.1 million (104 licensees x
$30,000/licensee). For a flow of funds at a 3 percent real discount
rate, the estimated savings per nuclear power plant and for the nuclear
power industry are $770,000 ($30,000 x 25.50) and $79 million ($3.1
million x 25.50), respectively. For a flow of funds at a 7 percent real
discount rate, the estimated savings per nuclear power plant and for
the nuclear power industry are $410,000 ($30,000 x 13.77) and $43
million ($3.1 million x 13.77), respectively.
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. Using an annual savings of
$30,000 per nuclear power plant and a staff rate of $105 per hour, the
annual burden reduction from implementing the regulatory action is
estimated to be 290 hours per plant ($30,000/licensee / $105/hour) and
the total annual industry burden reduction is 30,000 hours (290 hours/
licensee x 104 licensees).
[[Page 68054]]
3.3.4 Cumulative Occupational Radiation Dose
Nuclear power reactor licensees.
In implementing the regulatory action, nuclear power reactor
licensees will incur a one-time cost to revise procedures. The NRC
estimates it will take 20 hours to revise the procedures for each of
the 104 nuclear power plants. Assuming a staff rate of $105 per hour,
the one-time cost of implementing the regulatory action will be $2,100
per nuclear power plant (20 hours x $105/hour) and $220,000 for the
nuclear power industry (104 licensees x $2,100/licensee).
With respect to industry operation, there will be a savings from
not having to obtain the records of cumulative occupational radiation
dose (NRC Form 4) for a worker, unless these individuals are being
authorized to receive a planned special exposure. As discussed in the
regulatory analysis for the proposed rule (71 FR 55382; September 22,
2006), the NRC estimated the annual savings to be $8,500 per nuclear
power plant and $880,000 for the nuclear power industry ($8,500 x 104
licensees). Based on NUREG-0713, each nuclear power plant will annually
obtain the dose records for 230 workers. Also, based on public comment,
the NRC assumes that each worker has previously worked for two other
licensees and that these licensees will incur costs to provide the
worker's dose record to the requesting nuclear power plant licensee.
The average cost to each licensee to provide a dose record is estimated
to be $10. Thus, the estimated savings from not having to obtain the
dose records for each worker is $60 (($8,500/nuclear power plant / 230
workers) + (2 x $10/licensee providing the dose record)).\1\ The
estimated annual savings is $14,000 per nuclear power plant ($60/worker
x 230 workers) and $1.5 million for the nuclear power industry ($14,000
x 104 licensees). For a flow of funds at a 3 percent real discount
rate, the estimated savings per nuclear power plant and for the nuclear
power industry are $360,000 ($14,000 x 25.50) and $38 million ($1.5
million x 25.50), respectively. For a flow of funds at a 7 percent real
discount rate, the estimated savings per nuclear power plant and for
the nuclear power industry are $190,000 ($14,000 x 13.77) and $21
million ($1.5 million x 13.77), respectively.
---------------------------------------------------------------------------
\1\ To simplify the expression of annual burden reduction
(hours), the hours attributed to the requesting nuclear power plant
and responding licensees are combined and attributed solely to the
nuclear power plant.
---------------------------------------------------------------------------
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. Using an annual savings of
$14,000 per nuclear power plant and a staff rate of $105 per hour, the
annual burden reduction from implementing the regulatory action is
estimated to be 130 hours per plant ($14,000/licensee / $105/hour) and
the total annual industry burden reduction is 14,000 hours (130 hours/
licensee x 104 licensees).
REIRS materials licensees.
In implementing the regulatory action, REIRS materials licensees
will incur a one-time cost to revise procedures. The NRC estimates it
will take 10 hours to revise the procedures for each of the 123 REIRS
materials licensees. Assuming a staff rate of $105 per hour, the one-
time cost of implementing the regulatory action will be $1,050 per
licensee (10 hours x $105/hour) and $130,000 for all licensees in this
category (123 licensees x $1,050/licensee).
With respect to industry operation, using the 2004 data in NUREG-
0713, the number of individuals working for REIRS materials licensees
is 12,032. Assuming these workers are equally distributed among the 123
licensees in this group, there are about 98 workers per licensee. For
this analysis, the NRC assumes that 20 percent of all workers will be
affected and that 0.5 hours is required by each REIRS materials
licensee (i.e., the requesting licensee) to complete, review, and
authorize each NRC Form 4, ``Cumulative Occupational Dose History.''
Based on public comment, the NRC assumes that each worker has
previously worked for two other licensees and that these licensees will
incur costs to provide the worker's dose record to the requesting
licensee. The average cost to each licensee to provide a dose record is
estimated to be $10. Using a staff rate of $105 per hour for the
requesting licensee, the estimated savings from not having to request
the dose records (including the responses) for each worker is $75
(($105/hour x 0.5 hour/licensee requesting the dose record) + (2 x $10/
licensee providing the dose record)).\2\ The NRC is not aware of any
licensee having authorized a planned special exposure. For this
analysis, it is assumed that 99 percent of the NRC Forms 4 will not be
needed as the basis for authorizing a planned special exposure. Thus,
the estimated annual savings to industry is $180,000 (98 workers/
licensee x $75/worker x 0.2 x 0.99 x 123 licensees). For a flow of
funds at a 3 percent real discount rate, the estimated savings for
industry is $2.7 million ($180,000 x 14.9), respectively. For a flow of
funds at a 7 percent real discount rate, the estimated savings for
industry is $1.9 million ($180,000 x 10.6).
---------------------------------------------------------------------------
\2\ To simplify the expression of annual burden reduction
(hours), the hours attributed to the requesting REIRS materials
licensee and responding licensees are combined and attributed solely
to the REIRS materials licensee.
---------------------------------------------------------------------------
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. The annual burden reduction
from implementing the regulatory action is estimated to be 10 hours per
licensee ((98 workers/licensee x 0.5 hour/worker x 0.2 x 0.99) + (2 x
0.10 hour/licensee providing the dose record)) and 1,200 hours for
industry (10 hours/licensee x 123 licensees).
Non-REIRS materials licensees.
In implementing the regulatory action, non-REIRS materials
licensees will incur a one-time cost to revise procedures. The NRC
estimates it will take 10 hours to revise the procedures for each of
the 21,692 non-REIRS materials licensees. Assuming a staff rate of $105
per hour, the one-time cost of implementing the regulatory action will
be $1,050 per licensee (10 hours x $105/hour) and $23 million for all
licensees in this category (21,692 licensees x $1,050/licensee).
With respect to industry operation, the analysis assumes 500,000
individuals working under 21,692 non-REIRS licensees and an even
distribution of workers per licensee (23 workers/licensee). The NRC
also assumes that 20 percent of all workers will be affected and that
0.5 hours is required to complete, review, and authorize each NRC Form
4. Based on public comment, the NRC assumes that each worker has
previously worked for two other licensees and that these licensees will
incur costs to provide the worker's dose record to the requesting
licensee. The average cost to each licensee to provide a dose record is
estimated to be $10. Using a staff rate of $105 per hour for the
requesting licensee, the estimated savings from not having to request
the dose records (including the responses) for each worker is $75
(($105/hour x 0.5 hour/licensee requesting the dose record) + (2 x $10/
licensee providing the dose record)).\3\ The NRC is not aware of any
[[Page 68055]]
licensee having authorized a planned special exposure. For this
analysis, it is assumed that 99 percent of the NRC Forms 4 will not be
needed as the basis for authorizing a planned special exposure. Thus,
the estimated annual savings to industry is $7.4 million (23 workers/
licensee x $75/worker x 0.2 x 0.99 x 21,692 licensees). For a flow of
funds at a 3 percent real discount rate, the estimated savings for
industry is $110 million ($7.4 million x 14.9). For a flow of funds at
a 7 percent real discount rate, the estimated savings for industry is
$78 million ($7.4 million x 10.6).
---------------------------------------------------------------------------
\3\ To simplify the expression of annual burden reduction
(hours), the hours attributed to the requesting non-REIRS materials
licensee and responding licensees are combined and attributed solely
to the non-REIRS materials licensee.
---------------------------------------------------------------------------
In order to provide an estimate of the ``hourly'' burden reduction,
the NRC performed the following analysis. The annual burden reduction
from implementing the regulatory action is estimated to be 2.5 hours
per licensee ((23 workers/licensee x 0.5 hour/worker x 0.2 x 0.99) + (2
x 0.10 hour/licensee providing the dose record)) and 54,000 hours for
industry (2.5 hours/licensee x 21,692 licensees). For NRC licensees
only, the total annual burden reduction is estimated to be 11,000 hours
(2.5 hours/licensee x 4,394 NRC licensees).
3.3.5 NRC Implementation and Operating Impacts
Annual dose report to workers.
The NRC will incur costs to make minor revisions to NRC Form 3,
``Notice to Employees,'' to account for the revision to the reporting
of annual dose to workers under 10 CFR 19.13(b). The one-time cost for
this task is estimated to be $34,000 (320 staff-hours at $105 per
hour). This is the only impact to the NRC for this action.
Definition of Total Effective Dose Equivalent (TEDE).
The NRC will incur costs to make minor revisions to NRC Form 4,
``Cumulative Occupational Dose History,'' and NRC Form 5,
``Occupational Dose Record for a Monitoring Period,'' and their
instructions, to account for the revision to the definition of TEDE.
The one-time cost to revise NRC Forms 4 and 5 and their instructions is
estimated to be $34,000 (320 staff-hours at $105 per hour). This is the
only impact to the NRC for this action.
Labeling Containers.
The NRC will incur no implementation or operating impacts due to
the revision to the exemptions to labeling requirements for containers
holding licensed material under 10 CFR 20.1905.
Cumulative Occupational Radiation Dose.
The NRC will incur no implementation impacts due to the revision to
remove the requirement that licensees attempt to obtain cumulative
occupational radiation dose records for workers unless these
individuals are being authorized to receive a planned special exposure.
With respect to NRC operation, there will be a savings from not
having inspectors review the information on NRC Form 4, or its
equivalent, and supporting records maintained by licensees. For nuclear
power reactor licensees, it is estimated that 1 hour of inspection time
is spent reviewing such records at each of the 104 nuclear power
plants. Assuming an NRC staff rate of $105 per hour, the estimated
annual savings to the NRC is $11,000 (1 hour x 104 licensees x $105/
hour). For a flow of funds at 3 and 7 percent real discount rates, the
estimated savings to the NRC are $280,000 ($11,000 x 25.50) and
$150,000 ($11,000 x 13.77), respectively. The annual burden reduction
to the NRC from implementing the regulatory action is estimated to be
104 hours (1 hour x 104 licensees).
For each of the 123 REIRS materials licensees, it is estimated that
6 minutes (0.1 hour) of inspection time is spent reviewing NRC Form 4,
or its equivalent, and supporting records. The NRC is not aware of any
licensee having authorized a planned special exposure. For this
analysis, it is assumed that 99 percent of the NRC Forms 4 will not
need to be inspected as the basis for authorizing a planned special
exposure. Assuming an NRC staff rate of $105 per hour, the estimated
annual savings to the NRC is $1,300 (0.1 hour x 123 licensees x $105/
hour x 0.99). For a flow of funds at 3 and 7 percent real discount
rates, the estimated savings to the NRC are $19,000 ($1,300 x 14.9) and
$14,000 ($1,300 x 10.6), respectively. The annual burden reduction to
the NRC from implementing the regulatory action is estimated to be 12
hours (0.1 hour x 123 licensees x 0.99).
For each of the 4,394 NRC licensees designated as non-REIRS
materials licensees, it is estimated that 6 minutes (0.1 hour) of
inspection time is spent reviewing NRC Form 4, or its equivalent, and
supporting records. As discussed above, it is assumed that 99 percent
of the NRC Forms 4 will not need to be inspected as the basis for
authorizing a planned special exposure. Assuming an NRC staff rate of
$105 per hour, the estimated annual savings to the NRC is $46,000 (0.1
hour x 4,394 licensees x $105/hour x 0.99). For a flow of funds at 3
and 7 percent real discount rates, the estimated savings to the NRC are
$685,000 ($46,000 x 14.9) and $490,000 ($46,000 x 10.6), respectively.
The annual burden reduction to the NRC from implementing the regulatory
action is estimated to be 435 hours (0.1 hour x 4,394 licensees x
0.99).
3.3.6 Other Government Implementation and Operating Impacts
The Agreement States will incur no implementation or operating
impacts due to the revisions to the reporting of annual dose to
workers, the definition of TEDE, or the labeling of containers holding
licensed material. For the revisions to the reporting of annual dose to
workers and the definition of TEDE, the only impacts are to the NRC to
revise NRC Forms 3, 4, and 5. Also, because the revision to the
labeling of containers applies only to nuclear power plants licensed by
the NRC, there are no impacts to the Agreement States for this action.
Cumulative Occupational Radiation Dose.
For each of the 17,298 Agreement State licensees designated as non-
REIRS materials licensees, it is estimated that 6 minutes (0.1 hour) of
inspection time is spent reviewing NRC Form 4, or its equivalent, and
supporting records. As discussed above, it is assumed that 99 percent
of the NRC Forms 4 will not need to be inspected as the basis for
authorizing a planned special exposure. Assuming an Agreement State
staff rate of $105 per hour, the estimated annual savings to the
Agreement States is $180,000 (0.1 hour x 17,298 licensees x $105/hour x
0.99). For a flow of funds at 3 and 7 percent real discount rates, the
estimated savings to the Agreement States are $2.7 million ($180,000 x
14.9) and $1.9 million ($180,000 x 10.6), respectively. The annual
burden reduction to the Agreement States from implementing the
regulatory action is estimated to be 1,700 hours (0.1 hour x 17,298
licensees x 0.99).
4. Presentation of Results
Because each revision to the Commission's regulations will reduce
burden on licensees, which is the objective of this rulemaking, the
costs and benefits have been aggregated for this analysis. The results
of the NRC's value-impact assessment for industry implementation and
operation are summarized in the following table.
[[Page 68056]]
Table 1.--Summary of Industry Implementation and Operating Savings
[Costs]
----------------------------------------------------------------------------------------------------------------
Operating savings (costs)
Implementation ------------------------------------------
Final regulatory action Licensee category savings Using 7 percent Using 3 percent
(costs) discount rate discount rate
($1,000) ($1,000) ($1,000)
----------------------------------------------------------------------------------------------------------------
Annual Dose Report to Workers... Nuclear power (220) 4,300............... 8,000
reactor.
REIRS materials.... (130) 780................. 1,100
Non-REIRS materials (23,000) 32,000.............. 45,000
TEDE............................ Nuclear power n/a minimal............. minimal
reactor.
REIRS materials.... n/a minimal............. minimal
Non-REIRS materials n/a minimal............. minimal
Labeling Containers............. Nuclear power (220) 43,000.............. 79,000
reactor.
REIRS materials.... n/a n/a................. n/a
Non-REIRS materials n/a n/a................. n/a
Cumulative Occupational Nuclear power (220) 21,000.............. 38,000
Radiation Dose. reactor.
REIRS materials.... (130) 1,900............... 2,700
Non-REIRS materials (23,000) 78,000.............. 110,000
-------------------------------------------------------------------------------
Subtotals................... Nuclear power (660) 68,300.............. 125,000
reactor.
REIRS materials.... (260) 2,680............... 3,800
Non-REIRS materials (46,000) 110,000............. 155,000
===============================================================================
Total (rounded)......... ................... (47,000) 180,000............. 280,000
----------------------------------------------------------------------------------------------------------------
The results of the NRC's value-impact assessment for NRC
implementation and operation are summarized in the following table.
Table 2.--Summary of NRC Implementation and Operating Savings
[Costs]
----------------------------------------------------------------------------------------------------------------
Operating savings (costs)
Implementation -------------------------------
savings Using 7 Using 3
Final regulatory action Licensee category (costs) percent percent
($1,000) discount rate discount rate
($1,000) ($1,000)
----------------------------------------------------------------------------------------------------------------
Annual Dose Report to Workers......... Nuclear power reactor... .............. .............. ..............
REIRS materials......... (34) n/a n/a
Non-REIRS materials..... .............. .............. ..............
TEDE.................................. Nuclear power reactor... .............. .............. ..............
REIRS materials......... (34) n/a n/a
Non-REIRS materials..... .............. .............. ..............
Labeling Containers................... Nuclear power reactor... .............. .............. ..............
REIRS materials......... n/a n/a n/a
Non-REIRS materials..... .............. .............. ..............
Cumulative Occupational Radiation Dose Nuclear power reactor... .............. 150 280
REIRS materials......... n/a 14 19
Non-REIRS materials..... .............. 490 685
-----------------------------------------------
Total (rounded)................... ........................ (68) 650 980
----------------------------------------------------------------------------------------------------------------
The results of the NRC's value-impact assessment for Agreement
States implementation and operation are summarized in the following
table.
[[Page 68057]]
Table 3.--Summary of Agreement States Implementation and Operating Savings
[Costs]
----------------------------------------------------------------------------------------------------------------
Operating savings (costs)
Implementation -------------------------------
savings Using 7 Using 3
Final regulatory action (costs) percent percent
($1,000) discount rate discount rate
($1,000) ($1,000)
----------------------------------------------------------------------------------------------------------------
Annual Dose Report to Workers................................... n/a n/a n/a
TEDE............................................................ n/a n/a n/a
Labeling Containers............................................. n/a n/a n/a
Cumulative Occupational Radiation Dose.......................... n/a 1,900 2,700
-----------------------------------------------
Total (rounded)............................................. n/a 1,900 2,700
----------------------------------------------------------------------------------------------------------------
The results of the NRC's assessment of annual burden reduction in
hours per licensee and industry are summarized in the following table.
Table 4.--Summary of Annual Burden Reduction per Licensee and Industry
----------------------------------------------------------------------------------------------------------------
Annual burden reduction
(hours)
Final regulatory action Licensee category -------------------------------
Licensee Industry
----------------------------------------------------------------------------------------------------------------
Annual Dose Report to Workers................. Nuclear power reactor........... 63 6,600
REIRS materials................. 5 620
Non-REIRS materials............. 1.2 26,000
TEDE.......................................... Nuclear power reactor........... n/a n/a
REIRS materials................. n/a n/a
Non-REIRS materials............. n/a n/a
Labeling Containers........................... Nuclear power reactor........... 290 30,000
REIRS materials................. n/a n/a
Non-REIRS materials............. n/a n/a
Cumulative Occupational Radiation Dose........ Nuclear power reactor........... 130 14,000
REIRS materials................. 10 1,200
Non-REIRS materials............. 2.5 54,000
-----------------------------------------------------------------
Subtotals................................. Nuclear power reactor........... 483 50,600
REIRS materials................. 15 1,820
Non-REIRS materials............. 3.7 80,000
=================================================================
Total (rounded)....................... ................................ 500 130,000
----------------------------------------------------------------------------------------------------------------
The results of the NRC's assessment of annual burden reduction in
hours per NRC and Agreement States are summarized in the following
table.
Table 5.--Summary of Annual Burden Reduction per NRC and Agreement
States
------------------------------------------------------------------------
Annual burden reduction
(hours)
Final regulatory action -------------------------------
Agreement
NRC states
------------------------------------------------------------------------
Annual Dose Report to Workers........... n/a n/a
TEDE.................................... n/a n/a
Labeling Containers..................... n/a n/a
Cumulative Occupational Radiation Dose.. 550 1,700
-------------------------------
Total............................... 550 1,700
------------------------------------------------------------------------
The total implementation cost to the NRC for the regulatory action
is $68,000. The total operating impact to the NRC for a flow of funds
at 3 and 7 percent real discount rates is an estimated savings of
$980,000 and $650,000, respectively.
There are no implementation impacts to the Agreement States for the
regulatory action. The total operating impact to the Agreement States
for a flow of funds at 3 and 7 percent real discount rates is an
estimated savings of $2.7 million and $1.9 million, respectively.
The net present value of the regulatory action is $237 million at a
3
[[Page 68058]]
percent real discount rate [industry operation ($280 million) + NRC
operation ($980,000) + Agreement State Operation (2.7 million)]--[NRC
implementation ($68,000) + industry implementation ($47 million)]. The
net present value of the regulatory action is $135 million at a 7
percent real discount rate [industry operation ($180 million) + NRC
operation ($650,000) + Agreement State Operation (1.9 million)]--[NRC
implementation ($68,000) + industry implementation ($47 million)].
The total reduction in annual burden from implementing the
regulatory action is estimated to be 132,000 hours [industry (130,000
hours) + NRC (550 hours) + Agreement States (1,700 hours)].
5. Decision Rationale
The net present value of this regulatory action is $237 million and
$135 million for 3 and 7 percent real discount rates, respectively. The
total industry reduction in annual burden from implementing the
regulatory action is estimated to be 132,000 hours. These savings are
obtained by reducing administrative and information collection
requirements on licensees. The Commission is implementing this rule
because the changes improve the effectiveness of the Commission's
regulations and reduce unnecessary regulatory burden without affecting
the level of protection for either the health and safety of workers and
the public or for the environment.
6. Implementation Schedule
The final rule will become effective 30 days after its publication
in the Federal Register. No impediments to the implementation of the
recommended alternative have been identified.
XI. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule will not have a
significant economic impact upon a substantial number of small
entities. Although three of the changes (i.e., the reporting of annual
dose to workers, the definition of TEDE, and the determination of
cumulative occupational radiation dose) in the final rule pertain to
all 21,692 licensees regulated by the NRC and Agreement States,
licensees, including the affected small entities, could elect to
continue their current practices and remain in compliance with the
final regulations. Licensees will incur the costs of changing their
procedures only if they determine that the changes will be cost
effective; therefore, the NRC has determined that the changes will not
have a significant economic impact on licensees defined as small
entities. The change related to labeling containers affects only
licensees authorized to operate nuclear power reactors. These licensees
do not fall within the scope of the definition of ``small entities'' in
the Regulatory Flexibility Act or the scope of the size standards
established by the NRC in 10 CFR 2.810.
XII. Backfit Analysis
The NRC has determined that the backfit rule does not apply to this
rule and that a backfit analysis is not required for this rule because
these amendments do not involve any provisions that would impose
backfits as defined in 10 CFR chapter I.
XIII. Congressional Review Act
In accordance with the Congressional Review Act of 1996, the NRC
has determined that this action is a major rule and has verified this
determination with the Office of Information and Regulatory Affairs of
OMB.
List of Subjects
10 CFR Part 19
Criminal penalties, Environmental protection, Nuclear materials,
Nuclear power plants and reactors, Occupational safety and health,
Radiation protection, Reporting and recordkeeping requirements, Sex
discrimination.
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recordkeeping requirements, Source material, Special nuclear material,
Waste treatment and disposal.
10 CFR Part 50
Antitrust, Classified information, Criminal penalties, Fire
protection, Intergovernmental relations, Nuclear power plants and
reactors, Radiation protection, Reactor siting criteria, Reporting and
recordkeeping requirements.
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For the reasons set out in the preamble and under the authority of the
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of
1974, as amended; and 5 U.S.C. 553, the NRC is proposing to adopt the
following amendments to 10 CFR Parts 19, 20, and 50.
PART 19--NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION
AND INVESTIGATIONS
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1. The authority citation for part 19 continues to read as follows:
Authority: Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930,
933, 935, 936, 937, 948, 955, as amended, sec. 234, 83 Stat. 444, as
amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073,
2093, 2111, 2133, 2134, 2201, 2236, 2282, 2297f); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); Pub. L. 95-601, sec. 10, 92 Stat.
2951 (42 U.S.C. 5851); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504
note).
Section 19.32 is also issued under sec. 401, 88 Stat. 1254 (42
U.S.C. 5891).
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2. In Sec. 19.13, paragraphs (b) and (d) are revised to read as
follows:
Sec. 19.13 Notifications and reports to individuals.
* * * * *
(b) Each licensee shall make dose information available to workers
as shown in records maintained by the licensee under the provisions of
10 CFR 20.2106. The licensee shall provide an annual report to each
individual monitored under 10 CFR 20.1502 of the dose received in that
monitoring year if:
(1) The individual's occupational dose exceeds 1 mSv (100 mrem)
TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or
(2) The individual requests his or her annual dose report.
* * * * *
(d) When a licensee is required by Sec. Sec. 20.2202, 20.2203 or
20.2204 of this chapter to report to the Commission any exposure of an
individual to radiation or radioactive material, the licensee shall
also provide the individual a report on his or her exposure data
included in the report to the Commission. This report must be
transmitted no later than the transmittal to the Commission.
* * * * *
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
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3. The authority citation for part 20 continues to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701,
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133,
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846);
sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub.
L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).
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4. In Sec. 20.1003, the definition of Total Effective Dose Equivalent
is revised to read as follows:
[[Page 68059]]
Sec. 20.1003 Definitions.
* * * * *
Total Effective Dose Equivalent (TEDE) means the sum of the
effective dose equivalent (for external exposures) and the committed
effective dose equivalent (for internal exposures).
* * * * *
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5. In Sec. 20.1201, paragraph (c) is revised to read as follows:
Sec. 20.1201 Occupational dose limits for adults.
* * * * *
(c) When the external exposure is determined by measurement with an
external personal monitoring device, the deep-dose equivalent must be
used in place of the effective dose equivalent, unless the effective
dose equivalent is determined by a dosimetry method approved by the
NRC. The assigned deep-dose equivalent must be for the part of the body
receiving the highest exposure. The assigned shallow-dose equivalent
must be the dose averaged over the contiguous 10 square centimeters of
skin receiving the highest exposure. The deep-dose equivalent, lens-
dose equivalent, and shallow-dose equivalent may be assessed from
surveys or other radiation measurements for the purpose of
demonstrating compliance with the occupational dose limits, if the
individual monitoring device was not in the region of highest potential
exposure, or the results of individual monitoring are unavailable.
* * * * *
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6. In Sec. 20.1905, paragraph (f) is revised and paragraph (g) is
added to read as follows:
Sec. 20.1905 Exemptions to labeling requirements.
* * * * *
(f) Installed manufacturing or process equipment, such as reactor
components, piping, and tanks; or
(g) Containers holding licensed material (other than sealed sources
that are either specifically or generally licensed) at a facility
licensed under Parts 50 or 52 of this chapter, not including non-power
reactors, that are within an area posted under the requirements in
Sec. 20.1902 if the containers are:
(1) Conspicuously marked (such as by providing a system of color
coding of containers) commensurate with the radiological hazard;
(2) Accessible only to individuals who have sufficient instruction
to minimize radiation exposure while handling or working in the
vicinity of the containers; and
(3) Subject to plant procedures to ensure they are appropriately
labeled, as specified at Sec. 20.1904 before being removed from the
posted area.
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7. In Sec. 20.2104, paragraph (a), the introductory text of paragraph
(c), and paragraph (d) are revised to read as follows:
Sec. 20.2104 Determination of prior occupational dose.
(a) For each individual who is likely to receive an annual
occupational dose requiring monitoring under Sec. 20.1502, the
licensee shall determine the occupational radiation dose received
during the current year.
* * * * *
(c) In complying with the requirements of paragraphs (a) or (b) of
this section, a licensee may--
* * * * *
(d) The licensee shall record the exposure history of each
individual, as required by paragraphs (a) or (b) of this section, on
NRC Form 4, or other clear and legible record, including all of the
information required by NRC Form 4.\4\ The form or record must show
each period in which the individual received occupational exposure to
radiation or radioactive material and must be signed by the individual
who received the exposure. For each period for which the licensee
obtains reports, the licensee shall use the dose shown in the report in
preparing the NRC Form 4. For any period in which the licensee does not
obtain a report, the licensee shall place a notation on the NRC Form 4
indicating the periods of time for which data are not available.
* * * * *
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\4\ Licensees are not required to partition historical dose
between external dose equivalent(s) and internal committed dose
equivalent(s). Further, occupational exposure histories obtained and
recorded on NRC Form 4 before January 1, 1994, might not have
included effective dose equivalent, but may be used in the absence
of specific information on the intake of radionuclides by the
individual.
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8. Section 20.2205 is revised to read as follows:
440.250 [Amended]
Sec. 20.2205 Reports to individuals of exceeding dose limits.
When a licensee is required by Sec. Sec. 20.2203 or 20.2204 to
report to the Commission any exposure of an identified occupationally
exposed individual, or an identified member of the public, to radiation
or radioactive material, the licensee shall also provide the individual
a report on his or her exposure data included in the report to
Commission. This report must be transmitted no later than the
transmittal to the Commission.
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION
FACILITIES
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9. The authority citation for part 50 continues to read as follows:
Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68
Stat. 936, 937, 938, 948, 953, 954, 955, 956, as amended, sec. 234,
83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201,
2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846);
sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub.
L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).
Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 (42 U.S.C. 5841). Section 50.10 also issued under secs. 101,
185, 68 Stat. 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub.
L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd),
and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42
U.S.C. 2138).
Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec.
185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and
Appendix Q also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853
(42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under sec.
204, 88 Stat. 1245 (42 U.S.C. 5844). Sections 50.58, 50.91, and
50.92 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C.
2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42
U.S.C. 2152). Sections 50.80-50.81 also issued under sec. 184, 68
Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
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10. In Sec. 50.2, the definition of Total Effective Dose Equivalent is
revised to read as follows:
Sec. 50.2 Definitions.
* * * * *
Total Effective Dose Equivalent (TEDE) means the sum of the
effective dose equivalent (for external exposures) and the committed
effective dose equivalent (for internal exposures).
* * * * *
Dated at Rockville, Maryland, this 28th day of November 2007.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E7-23469 Filed 12-3-07; 8:45 am]
BILLING CODE 7590-01-P