Occupational Dose Records, Labeling Containers, and the Total Effective Dose Equivalent, 68043-68059 [E7-23469]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 72, Number 232 (Tuesday, December 4, 2007)]
[Rules and Regulations]
[Pages 68043-68059]
From the Federal Register Online via the Government Printing 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 
pdr@nrc.gov.

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 sxs4@nrc.gov.

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 https://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; sxs4@nrc.gov.

------------------------------------------------------------------------
           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; https://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 https://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 INFOCOLLECTS@NRC.GOV; 
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