[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Proposed Rules]
[Pages 55382-55398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15502]


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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: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC or Commission) is 
proposing to amend its regulations related to the reporting of annual 
dose to workers, the definition of the total effective dose equivalent 
(TEDE), the labeling of certain containers holding licensed material, 
and the determination of cumulative occupational radiation dose. The 
proposed rule would limit the routine reporting of annual doses to 
workers to those whose annual dose exceeds a specific dose threshold or 
who request a report. The proposed rule would also amend the definition 
of TEDE to be consistent with current Commission policy. The proposed 
rule would also modify the labeling requirements for certain containers 
holding licensed material within posted areas in nuclear power 
facilities. Finally, the proposed rule would remove 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 would reduce the 
administrative and information collection burdens on NRC and Agreement 
State licensees without affecting the level of protection to either the 
health and safety of workers and the public or the environment.

DATES: Submit comments on this proposed rule by December 6, 2006. 
Submit comments on the information collection aspects of this proposed 
rule by October 23, 2006. Comments received after the above dates will 
be considered if it is practical to do so, but assurance of 
consideration cannot be given to comments received after these dates.

ADDRESSES: You may submit comments by any of the following methods. 
Please include the following number RIN 3150-AH40 in the subject line 
of your comments. Comments on rulemakings submitted in writing or in 
electronic form will be made available for public inspection. Because 
your comments will not be edited to remove any identifying or contact 
information, the NRC cautions you against including personal 
information such as social security numbers and birth dates in your 
submission.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us 
directly at (301) 415-1966. You may also submit comments via the NRC's 
rulemaking Web site at http://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail 
[email protected]. Comments can also be submitted via the Federal eRulemaking 
Portal http://www.regulations.gov.
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone 
(301) 415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
(301) 415-1101.
    Publicly available documents related to this rulemaking may be 
viewed electronically on the public computers located at the NRC's 
Public Document Room (PDR), O1 F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor 
will copy documents for a fee. Selected documents, including comments, 
may be viewed and downloaded electronically via the NRC rulemaking Web 
site at http://ruleforum.llnl.gov.
    Publically available documents created or received at the NRC after 
November 1, 1999, are available electronically at the NRC's Electronic 
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this 
site, the public can gain entry into 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, 
contact the NRC Public Document Room (PDR) Reference staff at 1-800-
397-4209, 301-415-4737 or by e-mail to [email protected].
    You may submit comments on the information collections by the 
methods indicated in the Paperwork Reduction Act Statement.

[[Page 55383]]


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. Public Comments in Response to the Federal Register Notice
IV. Agreement State Comments on the Draft Rule Language
V. Section-by-Section Analysis of Substantive Changes
VI. Agreement State Compatibility
VII. Availability of Documents
VIII. Plain Language
IX. Voluntary Consensus Standards
X. Environmental Impact: Categorical Exclusion
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfit Analysis

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. 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 further this goal, the NRC published a notice of a public 
workshop and a request for comments in the Federal Register (66 FR 
22134; May 3, 2001). The notice indicated that the workshop would focus 
on three areas associated with reducing unnecessary regulatory burden: 
(1) Risk informing portions of 10 CFR Part 50, (2) reforming outdated 
or paperwork oriented regulations, and (3) reviewing other regulatory 
requirements (e.g., technical specifications) for burden reduction 
opportunities.
    Following the May 31, 2001, public workshop, the Nuclear Energy 
Institute (NEI) provided a comment letter dated July 2, 2001 (ADAMS No. 
ML011870432), which contained industry suggestions for possible burden-
reduction changes to various regulations. Under the category Radiation 
Protection, NEI proposed changes to 10 CFR 19.13, ``Notifications and 
reports to individuals,'' 10 CFR 20.1904, ``Labeling containers,'' and 
10 CFR 20.2104, ``Determination of prior occupational dose.''
    In SECY-02-0081, ``Staff Activities Related to the NRC Goal of 
Reducing Unnecessary Regulatory Burden on Power Reactor Licensees,'' 
dated May 13, 2002, the NRC staff described its interactions with 
stakeholders regarding ways to reduce unnecessary regulatory burden and 
requested Commission approval of its plans to reduce burden. In its 
Staff Requirements Memorandum (SRM) in response to SECY-02-0081, dated 
June 25, 2002, the Commission approved the proposal to reduce 
unnecessary regulatory burden on power reactor licensees by developing 
proposed rulemakings from short-term, limited-scope initiatives without 
preparing formal rulemaking plans.
    This proposed rule addresses the regulatory changes that NEI 
suggested under the Radiation Protection category. The NRC has 
determined that the regulations suggested for revision by NEI currently 
impose an undue regulatory burden on licensees. Additional changes NEI 
proposed to other areas of the Commission's regulations have been or 
are being assessed separately by the NRC.
    The NRC also proposes in this proposed rule to revise 10 CFR 
20.1003, ``Definitions,'' and 10 CFR 50.2, ``Definitions,'' to specify 
the use of effective dose equivalent in place of the deep-dose 
equivalent in the definition of total effective dose equivalent (TEDE) 
in 10 CFR Parts 20 and 50. This revision is consistent with current 
Commission policy.
    As part of the development of this rule, the NRC prepared draft 
rule language. The NRC solicited comments from the Agreement States and 
Minnesota and Pennsylvania (two Agreement State candidates) on the 
draft rule language in All Agreement States Letter STP-04-002, dated 
January 9, 2004. The NRC also solicited public comment on the draft 
rule language (69 FR 8350; February 24, 2004). The NRC considered the 
comments received during the development of this proposed rule.

II. Discussion

    Four principal amendments are being considered as part of this 
proposed rule.

A. Annual Dose Report to Workers

    The first proposed amendment would revise paragraphs (b) and (d) of 
10 CFR 19.13, ``Notifications and reports to individuals,'' and 10 CFR 
20.2205, ``Reports to individuals of exceeding dose limits.'' The 
proposed revisions are intended to resolve two separate issues.
    10 CFR 19.13(b) provides that each licensee shall advise each 
worker annually of the worker's dose as shown in records maintained by 
the licensee pursuant to the provisions of 10 CFR 20.2106. 10 CFR 
20.2106(a) requires that each licensee must maintain records of doses 
received by all individuals for whom monitoring was required pursuant 
to 10 CFR 20.1502.
    10 CFR 20.1502, ``Conditions requiring individual monitoring of 
external and internal occupational dose,'' paragraph (a)(1), requires 
licensees to provide monitoring for individuals likely to receive, from 
sources external to the body, an annual dose that exceeds ten percent 
of the limits in 10 CFR 20.1201(a). Licensees conservatively determine 
who should be monitored under 10 CFR 20.1502 because there is 
uncertainty about who is likely to exceed this criterion and because 
this is a prospective determination. As a result of this conservatism 
many of the individuals monitored under 10 CFR 20.1502 receive very low 
doses. However, 10 CFR 20.2206, ``Reports of individual monitoring,'' 
requires licensees to submit an annual report to the Commission of the 
results of individual monitoring for each individual for whom 
monitoring was required under 10 CFR 20.1502. In addition, under 10 CFR 
19.13(d) and 20.2205, these records of low doses must be reported to 
individuals. Further, 10 CFR 19.13(b) requires licensees to annually 
report doses to workers. This regulatory requirement results in 
licensees generating numerous reports of doses far below the regulatory 
limits in 10 CFR 20.1201(a).
    The NRC is proposing a change to the notification requirement in 10 
CFR 19.13(b) so that licensees would provide reports to occupationally 
exposed individuals whose annual dose exceeds 1 millisievert (mSv) (100 
millirem (mrem)) TEDE or 1 mSv (100 mrem) to any individual organ or 
tissue in the preceding year. However, licensees would not be required 
to provide unsolicited annual dose reports to those individuals whose 
annual dose does not exceed these limits. Individuals whose annual dose 
does not exceed these limits would still be provided with their dose 
reports upon request. This criterion would be applicable to the whole 
body, to the lens of the eye, to the skin of the whole body, and to the 
skin of the extremities. The criterion of 1 mSv (100 mrem) was selected 
because it corresponds to the occupational dose threshold for requiring 
instruction to workers under 10 CFR 19.12, ``Instruction to workers.''
    In the draft rule language previously published by the NRC (69 FR 
8350; February 24, 2004), the proposed threshold for reporting doses to 
individuals was two percent of the dose

[[Page 55384]]

limits in 10 CFR 20.1201(a). Use of a two-percent criterion would 
result in a different reporting threshold for doses to the whole body 
(i.e., 1 mSv (100 mrem)), to the lens of the eye (i.e., 3 mSv (300 
mrem)), and to the skin of the whole body or to the skin of any 
extremity (i.e., 10 mSv (1000 rem)). The NRC determined that it is 
preferable to use the requirement for instructions to workers in 10 CFR 
19.12 as the basis for the reporting threshold. Because licensees are 
required to provide instructions when an individual is likely to 
receive an annual occupational dose in excess of 1 mSv (100 mrem), only 
one threshold for providing reports would apply to all of the 
occupational dose limits in 10 CFR 20.1201(a). This approach is simpler 
because there is one reporting threshold instead of three and results 
in the same reduction in burden.
    Under 10 CFR 20.2206, seven categories of licensees are required to 
submit an annual report of radiation exposure for each monitored 
individual to the NRC. Each year, the NRC publishes a NUREG report that 
summarizes this occupational radiation exposure data. The latest 
publication, 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). Further, 61,725 of the monitored 
individuals received no measurable exposure.
    Based upon this information, the proposed change to the regulations 
would result in a significant reduction in administrative and reporting 
burdens on licensees. The proposed amendment would not change the 
current requirements for recordkeeping or for reporting to the NRC. The 
proposed rule would still require licensees to make all dose 
information available to workers. Therefore, the proposed amendment 
would not affect the level of protection to either the health and 
safety of workers and the public or the environment.
    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. The requirement appears in 10 CFR 19.13(d) 
through the reference to 10 CFR 20.2206. It also appears in 10 CFR 
20.2205 through the reference to 10 CFR 20.2206. To improve regulatory 
efficiency, the proposed rule would remove the reference to 10 CFR 
20.2206 in 10 CFR 19.13(d) and 10 CFR 20.2205, and the requirement to 
report annual dose to the individual would be consolidated into a 
single requirement in 10 CFR 19.13(b).
    NRC Form 3, ``Notice to Employees,'' will also need to be revised 
to reflect the changes to the requirements for reporting doses to 
individuals if this rule is promulgated.

B. Definition of Total Effective Dose Equivalent (TEDE)

    The second proposed amendment would revise the definition of TEDE 
in 10 CFR 20.1003, ``Definitions,'' and 50.2, ``Definitions.'' The TEDE 
is currently defined as the sum of the deep-dose equivalent (for 
external exposures) and the committed effective dose equivalent (for 
internal exposures). The proposed change would allow licensees to 
substitute ``effective dose equivalent'' for ``deep-dose equivalent'' 
for external exposures.
    The purpose of this revision is to 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 effective dose equivalent is the primary 
quantity in the definition of TEDE for external exposures but that 
licensees are required to use the deep-dose equivalent for the whole 
body in place of the effective dose equivalent when measuring dose from 
external exposure, unless the effective dose equivalent is determined 
by a dosimetry method approved by the NRC.
    In 10 CFR 20.1201, paragraph (c) would also be 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. The current requirement in paragraph (c) 
that the assigned deep-dose equivalent must be for the part of the body 
receiving the highest exposure remains unchanged.
    The proposed amendment would not affect the level of protection to 
either the health and safety of workers and the public or the 
environment because the revised definition of TEDE does not decrease 
the ability to determine dose.

C. Labeling Containers

    The third proposed amendment would revise 10 CFR 20.1905, 
``Exemptions to labeling requirements.'' 10 CFR 20.1905 currently 
provides exemptions to the labeling requirements in 10 CFR 20.1904 for 
situations where: (1) The amount of radioactive material is small 
enough not to present a significant radiation hazard; (2) packages 
which are in transport and are labeled pursuant to other regulations 
(i.e., U.S. Department of Transportation) that provide for adequate 
labeling; or (3) equipment for which the type of equipment or the 
accessibility of the equipment may make labeling impractical.
    The NRC is proposing to amend 10 CFR 20.1905 to add 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 would not be required to 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 instructions to minimize radiation exposure while handling 
or working in the vicinity of the containers. However, the proposed 
revision would require the container to be appropriately labeled under 
the requirements of 10 CFR 20.1904 before being removed from the posted 
area.
    In the Federal Register document that solicited public comment on 
the draft rule language (69 FR 8350; February 24, 2004), the NRC 
indicated that this proposed change would either revise 10 CFR 20.1905 
or add a new requirement to 10 CFR Part 50. The NRC proposes that the 
new exemption to labeling requirements be contained in 10 CFR 20.1905 
because it fits logically with the other exemptions in that section. In 
the February 24, 2004, Federal Register document, the NRC also asked 
whether in addition to nuclear power facilities, there were categories 
of materials

[[Page 55385]]

licensees to which this exemption might be applied and whether adequate 
controls for radioactive materials stored within these licensees' 
facilities could be provided by the conditions being considered for the 
exemption. No categories of materials licensees responded to this 
question. The NRC is proposing that this exemption apply only to 
nuclear power reactor licensees, not to materials or non-power reactor 
licensees.
    Some nuclear power reactor licensees have interpreted 10 CFR 
20.1904 to mean that all containers in a posted area, whether they 
contain licensed material or not, must be labeled because every 
container has the potential for internal contamination. This 
conservative interpretation of the regulations has put an undue burden 
on these licensees. The proposed revision to 10 CFR 20.1905 would 
require containers to be conspicuously marked commensurate with the 
radiological hazard. This would exempt 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 currently required under 10 CFR 20.1905. One 
purpose of adding conspicuous markings on the containers would be 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. Workers would be instructed on the 
handling of marked containers before workers were given access to these 
containers.
    The proposed container marking system would reduce licensee 
administrative and information collection burdens, but serve the same 
health and safety functions as the current labeling requirements. 
Therefore, the proposed amendment would not affect the level of 
protection to either the health and safety of workers and the public or 
the environment.
    The NRC has determined that the exemption to labeling requirements 
under 10 CFR 20.1905 is not appropriate for materials licensees because 
of the many types of radioactive material in containers at facilities 
such as hospitals and universities. Also, the NRC proposes not to make 
this exemption applicable to non-power reactor licensees because the 
operations at these facilities are not routine and must be addressed on 
a case-by-case basis. Highly radioactive materials are frequently taken 
out of these reactors and exempting these reactors from the labeling 
requirements could potentially present a significant health and safety 
concern.
    This proposed rule excludes sealed sources from the revision to the 
exemption to labeling requirements. This exclusion represents a change 
from the draft rule language (69 FR 8350; February 24, 2004). The NRC 
has determined that sealed sources such as those used for calibration 
or check sources should not be included in the proposed revision to 10 
CFR 20.1905 because these sources are usually either specifically or 
generally licensed and should be managed, used, and stored in 
accordance with the regulations. Therefore, the proposed amendment 
would not exempt them from the labeling requirements.

D. Cumulative Occupational Radiation Dose

    The fourth proposed amendment would remove 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.
    Initially, occupational exposures were 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.
    The proposed amendment would 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 proposed amendment to 10 CFR 20.2104(a)(2) would result in a 
significant reduction in administrative and information collection 
burdens on licensees and would not affect the level of protection to 
either the health and safety of workers and the public or the 
environment, since the requirements to determine an individual's dose 
during the current year or cumulative dose prior to permitting a 
planned special exposure would not be amended.
    In 10 CFR 20.2104, paragraphs (c) and (d) would 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 would add 
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. Public Comments in Response to the Federal Register Notice

    The February 24, 2004, Federal Register document presenting the 
draft rule language (69 FR 8350) solicited public comment on a number 
of questions about the proposed language. The Commission received eight 
comment letters. Comment letters were received from utility 
representatives, power reactor licensees, a fuel facility licensee, an 
industry organization representing materials licensees, and a member of 
the public. The majority of comment letters supported NRC's approach. 
The significant comments discussed below are arranged by subject. No 
changes to the draft rule language were made as a result of the comment 
letters. Agreement State comments are addressed separately below in 
Section IV.

A. Annual Dose Report to Workers

    All of the commenters supported the intent of the proposed revision 
to 10 CFR 19.13 to remove the requirement

[[Page 55386]]

that licensees provide unsolicited annual dose reports to workers who 
receive less than a threshold dose in a monitoring year. However, one 
industry commenter disagreed with the NRC's proposed threshold value of 
1 mSv (100 mrem) and believed it should be linked to the monitoring 
threshold for occupational exposure.
    Comment. One industry commenter stated that 10 CFR 20.1502 only 
requires licensees to monitor worker external exposure when there is 
reasonable expectation that the worker could exceed 5 mSv (500 mrem) in 
a year. The commenter therefore recommended that licensees should not 
be required to inform workers unless their annual exposure exceeds ten 
percent (i.e., 5 mSv (500 mrem)) of the limits.
    Response. The NRC disagrees with this comment. The criterion of 1 
mSv (100 mrem) was selected because it corresponds to the occupational 
dose threshold for requiring instructions to workers under 10 CFR 
19.12, ``Instructions to workers.'' While the commenter's suggested 
threshold of 5 mSv (500 mrem) per year is a possible option, the 
occupational exposure data in NUREG-0713, Volume 26, indicates that 
raising the threshold from the proposed value of 1 mSv (100 mrem) would 
not significantly reduce administrative and information collection 
burdens on licensees.
    Comment. Another commenter representing the nuclear power industry 
suggested that NRC clarify that the applicability of the criterion is 
limited to the occupational dose received from work activities at a 
specific facility, and is not applicable to the cumulative annual dose 
received from work activities at all (multiple) licensee facilities 
during the year.
    Response. The NRC believes that the applicability of the criterion 
is clear and no further changes are required. Nuclear power reactor 
licensees generally provide a separate occupational dose record (NRC 
Form 5, ``Occupational Dose Record for a Monitoring Period'') to an 
individual for each facility reflecting the dose received at that 
facility. Under the proposed regulations, the licensee would be 
required to provide only those reports (NRC Forms 5) to an individual 
whose recorded dose exceeded the reporting threshold of 1 mSv (100 
mrem) at that facility.
    Comment. The NRC also solicited comment on whether the proposed 
changes would result in cost savings to licensees and, if so, how much. 
Further, the NRC requested that stakeholders estimate the costs of 
implementing this possible change. One commenter representing the 
nuclear power industry stated that 10 CFR Part 50 licensees have 
estimated a cost savings of $1,000 to more than $5,000 per year due to 
the proposed change. Another commenter representing an alliance of six 
nuclear power utilities estimated the savings to be over $1,000 per 
plant per year. Still another reactor industry commenter estimated that 
the cost savings would be approximately $5,000 per site per year in 
administrative, supplies, and management time with a total estimated 
savings of $85,000 to $125,000 for the licensee's fleet of nuclear 
power plants and that implementation costs would be insignificant. 
Lastly, a commenter representing manufacturers and distributors of 
radiopharmaceuticals, radioactive sources, and research radionuclides 
stated that a manufacturing licensee who monitors 300 employees for 
radiation exposure and who manages the data electronically, might save 
only $100 per year, but that a licensee who manages the data manually 
might realize substantially larger cost savings from the changes under 
consideration.
    Response. The savings estimates provided by the three commenters 
from the nuclear power industry are generally consistent. The 
regulatory analysis in Section XII uses a $3,000 cost-savings value, 
the midpoint of the values provided by the first commenter, to estimate 
the annual savings per nuclear power plant. The estimate that the 
savings might be only $100 per year for materials licensees was based 
on the use of an electronic data management system. For all other 
licensees, NRC used an estimated savings of $10 per individual, 
assuming that these licensees do not have an electronic data management 
system.

B. Definition of Total Effective Dose Equivalent (TEDE)

    Seven commenters addressed this issue and all agreed with the 
proposed revision to the definition of TEDE in 10 CFR 20.1003 and 50.2.

C. Labeling Containers

    In the Federal Register document, the NRC solicited comments on 
whether to revise 10 CFR 20.1905 or to add a new regulation to 10 CFR 
Part 50, and whether there are categories of materials licensees to 
which the labeling exemption might be applied.
    Five industry commenters supported the proposed exemption to the 
labeling requirements. Three commenters favored revising 10 CFR 
20.1905. Two commenters preferred adding a new regulation to 10 CFR 
Part 50. As discussed above in Section II, the NRC proposes that the 
new exemption to labeling requirements be contained in 10 CFR 20.1905 
because it fits logically with the other exemptions in this section.
    The NRC received no comments from materials licensees that 
addressed the labeling exemption. As discussed above in Section II, the 
NRC proposes that this exemption apply only to nuclear power 
facilities, not to materials or non-power reactor licensees.
    Comment. An industry commenter suggested that the rule should 
require the labeling of containers of radioactive material before they 
are removed from a restricted area instead of a posted area, and that 
container markings should be required only when the container was in an 
area not otherwise adequately posted and controlled.
    Response. The NRC disagrees with this comment. The NRC has 
determined that the previously published draft language pertaining to 
this requirement is appropriate for the control of containers, and that 
the proposed language affords significant relief to the licensees while 
maintaining necessary controls on radioactive materials to protect 
workers from preventable contaminations or exposures. The proposed 
revision would also require the container to be appropriately labeled 
under the requirements of 10 CFR 20.1904 before being removed from the 
posted area.
    Comment. In response to the NRC's request for comments on whether 
the proposed changes would result in cost savings to licensees, one 
commenter representing the nuclear power industry stated that 10 CFR 
Part 50 licensees have estimated a cost savings of $10,000 to more than 
$50,000 per year from the proposed change. A second commenter 
representing an alliance of six nuclear power utilities estimated the 
savings to be $50,000 per year in technician and supervisory person-
hours. A third commenter stated that licensees would realize a savings 
of about $25,000 per year due to a reduction in the use of radioactive 
material labels and staff needed to ensure staging areas within the 
radiological controlled area have appropriate labels.
    Response. The savings estimates provided by the three commenters 
from the nuclear power industry are generally consistent. The 
regulatory analysis in Section XII uses a $30,000 cost-savings value, 
the midpoint of the values provided by the first commenter, to estimate 
the annual savings per nuclear power plant.

[[Page 55387]]

D. Cumulative Occupational Radiation Dose

    Comment. All industry commenters agreed with the intent of the 
proposed revision to 10 CFR 20.2104 to delete the requirement that 
licensees obtain the records of cumulative dose for all workers who 
require monitoring. However, a member of the public expressed concern 
that the proposed rule change would give workers the impression that 
lifetime dose is not important.
    Response. As explained above in Section II, the cumulative lifetime 
dose is no longer used in the Commission's regulations to restrict an 
individual's annual occupational exposure but it is used in special 
circumstances such as a planned special exposure. The proposed rule 
would not change the requirement in 10 CFR 20.1206 to ascertain an 
individual's cumulative lifetime dose prior to permitting the 
individual to participate in a planned special exposure.
    Comment. In response to the NRC's request for comments on whether 
the proposed changes would result in cost savings to licensees, one 
commenter representing the nuclear power industry indicated that 10 CFR 
Part 50 licensees have estimated a cost savings of $2,000 to more than 
$15,000 per year from the proposed change. Another commenter 
representing an alliance of six nuclear power utilities estimated that 
the savings could be as much as $100,000 per plant per year. Lastly, a 
commenter representing manufacturers and distributors of 
radiopaharmaceuticals, radioactive sources, and research radionuclides 
noted that most recently hired employees in the manufacturing industry 
do not have prior dose records. As an example, this commenter also 
mentioned that one manufacturer with 250 radiation workers made only 
three requests for records in 2003. The estimated savings was $30 per 
year for the three requests.
    Response. The regulatory analysis in Section XII uses an $8,500 
cost-savings value, the midpoint of the values provided by the first 
commenter, to estimate the annual savings per nuclear power plant. The 
second commenter's estimate of $100,000 per year was not used because 
it represented the savings for a few operating plants and is much 
higher than the savings estimated by the first commenter for the entire 
nuclear power industry. The NRC uses a savings of $10 per individual 
for all other licensees. This is consistent with the information 
provided by the commenter representing materials licensees.

IV. Agreement State Comments on the Draft Rule Language

    The NRC solicited comments from the Agreement States and Minnesota 
and Pennsylvania (two Agreement State candidates) in All Agreement 
States Letter STP-04-002, dated January 9, 2004. Comments on this 
letter were received from the Agreement States Illinois and Washington. 
No changes to the draft rule language were made as a result of the 
Agreement State comments.
    Comment. The State of Washington commented that the proposed 
reporting threshold for providing annual dose reports to workers under 
10 CFR 19.13(b) should be ten percent (5 mSv (500 mrem)) of the 
occupational dose limit for adults, not two percent (1 mSv (100 mrem)) 
of this dose limit.
    Response. While the commenter's suggested threshold of 5 mSv (500 
mrem) per year is a possible option, the occupational exposure data in 
NUREG-0713, Volume 26, indicates that raising the threshold from the 
proposed value of 1 mSv (100 mrem) would not significantly reduce 
administrative and information collection burdens on licensees. The NRC 
has determined that the proposed threshold of 1 mSv (100 mrem) 
reasonably balances reducing unnecessary regulatory burden and the need 
to keep individuals informed of their occupational dose.
    Comment. The State of Washington suggested that facilities 
providing dosimetry to all individuals would most likely see a cost 
savings from the reduced administrative person-hours needed to prepare, 
send and track these reports and the lower cost to produce and 
distribute these reports. The State of Washington also stated that the 
actual cost savings cannot easily be quantified, as it is dependent on 
the number of monitored individuals and the method used to inform these 
individuals of their dose.
    Response. The NRC agrees that it is difficult to estimate the 
savings to licensees from not having to prepare and distribute annual 
dose reports when the dose to an individual does not exceed 1 mSv (100 
mrem). However, the NRC is using other commenters' estimates of savings 
in the regulatory analysis (see Section XII).
    Comment. The State of Washington commented that the exemption to 
labeling requirements for containers holding radioactive material in a 
posted area in a nuclear power facility should be in 10 CFR Part 50.
    Response. As discussed in Section II, the NRC proposes that the new 
exemption to labeling requirements be contained in 10 CFR 20.1905 
because it fits logically with the other exemptions in this section.
    Comment. The State of Washington commented that quantifying the 
actual cost savings from not having to obtain prior dose records 
depends on the number of individuals for whom prior dose histories were 
required and the processes used to obtain the information.
    Response. The NRC agrees that it is difficult to estimate the 
savings to licensees from not having to attempt to obtain the lifetime 
dose records for individuals. However, the NRC is using other 
commenters' estimates for savings in the regulatory analysis (see 
Section XII).

V. Section-by-Section Analysis of Substantive Changes

    The Commission is proposing to amend 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) would be 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) would be 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) would be 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) would be 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) would be added to 10 CFR 20.1905 to provide an

[[Page 55388]]

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 regulations would not require the licensee to label 
the container per the requirements of 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 instructions to minimize radiation exposure while handling 
or working in the vicinity of the containers. The container would have 
to be appropriately labeled as required by 10 CFR 20.1904 before being 
removed from the posted area. The exemption to the labeling 
requirements for containers holding licensed material would not apply 
to non-power reactor and materials licensees, or for sealed sources.

Section 20.2104--Determination of Prior Occupational Dose

    Paragraph (a)(2) would be removed to delete the requirement that 
licensees attempt to obtain the records of cumulative occupational 
radiation dose. Paragraphs (a) and (a)(1) would then be combined and 
designated as paragraph (a). Paragraphs (c) and (d) would also be 
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 would be 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 50.2, the definition of total effective dose equivalent 
(TEDE) would be 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).

VI. 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 proposed rule would be a matter of compatibility between 
NRC and the Agreement States, that provides for consistency between 
Agreement State and NRC requirements. The NRC analyzed the proposed 
rule under 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://www.hsrd.ornl.gov/nrc/home.html). The NRC has determined that the compatibility categories 
for the sections amended in this proposed rule would be the same as for 
the sections in the current 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 is not required to 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 CFR provisions.
    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.

VII. 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.
    Rulemaking Web site (RuleForum). The NRC's Interactive rulemaking 
Web site is located at http://ruleforum.llnl.gov. These documents may 
be viewed and downloaded electronically via this Web site.
    NRC's Agency-wide Documents Access and Management System (ADAMS). 
The NRC's PARS Library is located at http://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             RuleForum            ADAMS            NRC staff
----------------------------------------------------------------------------------------------------------------
Comments received...................                  X                  X  .................                  X
NEI comment letter, July 2, 2001....                  X                  X        ML011870432  .................
NRC Strategic Plan FY 2000-2005.....                  X                  X  .................  .................
SECY-02-0081, ``Staff Activities                      X                  X        ML020420137  .................
 Related to the NRC Goal of Reducing
 Unnecessary Burden,'' (May 13,
 2002)..............................
SRM-SECY-02-0081(June 25, 2002).....                  X                  X        ML021760768  .................
Agreement State Letter STP-04-002...                  X                  X        ML040090486  .................
NRC Form 3, ``Notice to Employees''.                  X                  X  .................                  X
NRC Form 4, ``Cumulative                              X                  X  .................                  X
 Occupational Dose History''........
Form 5, ``Occupational Dose Record                    X                  X  .................                  X
 for a Monitoring Period''..........
NUREG-0713, Vol. 26.................                  X  .................  .................                  X
NUREG-1350, Vol. 17.................                  X  .................  .................                  X
NUREG/BR-0184.......................                  X  .................  .................                  X
NUREG/BR-0058.......................                  X  .................  .................                  X
56 FR 23391; May 21, 1991...........                  X                  X  .................  .................
----------------------------------------------------------------------------------------------------------------


[[Page 55389]]

    Copies of NUREGs may be purchased from The Superintendent of 
Documents, U.S. Government Printing Office, Mail Stop SSOP, Washington, 
DC 20402-0001; Internet: http://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.

VIII. Plain Language

    The Presidential memorandum ``Plain Language in Government 
Writing'' published June 10, 1998 (63 FR 31883), directed that the 
Government's documents be in clear and accessible language. The NRC 
requests comments on the proposed rule specifically with respect to the 
clarity and reflectiveness of the language used. Comments should be 
sent to the address listed under the ADDRESSES caption of this notice.

IX. 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 proposed rule, the NRC is proposing to 
revise requirements for the reporting of annual dose to workers, the 
definition of the total effective dose equivalent (TEDE), the labeling 
of certain containers holding licensed material, and the determination 
of cumulative occupational radiation dose. This proposed regulatory 
action does not constitute the establishment of a standard that 
contains generally applicable requirements.

X. Environmental Impact: Categorical Exclusion

    The NRC has determined that the proposed amendments to 10 CFR Parts 
19, 20, and 50 are the type 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 proposed 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 proposed amendments to the 
definition of TEDE in 10 CFR 20.1003 and 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 this revision is of a minor 
nature and does not substantially modify existing regulations. For the 
proposed 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 proposed 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).

XI. Paperwork Reduction Act Statement

    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). The rule would reduce the burden for existing information 
collection requirements. This rule has been submitted to the Office of 
Management and Budget for review and approval of the paperwork 
requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR Parts 19, 20, and 
50; ``Occupational Dose Records, Labeling Containers, and the Total 
Effective Dose Equivalent,'' proposed rule.
    The form number if applicable: NRC Form 4; ``Cumulative 
Occupational Dose History.''
    How often the collection is required: 10 CFR 19, 20, and NRC Form 
4--on occasion.
    Who will be required or asked to report: Nuclear power reactor 
licensees and materials licensees.
    An estimate of the number of annual responses: 10 CFR Part 19: 
4,621 (104 power reactor licensee recordkeepers and 4,517 materials 
licensee recordkeepers; NRC Form 4: 227 (104 nuclear power reactor 
recordkeepers and 123 materials recordkeepers).
    The estimated number of annual respondents: 10 CFR Part 19: 4,621 
recordkeepers (104 power reactor licensees and 4,517 materials 
licensees); NRC Form 4: 227 (104 nuclear power reactor licensees and 
123 materials licensees).
    An estimate of the total number of hours needed annually to 
complete the requirement or request: A reduction of 10,882 hours total 
for 10 CFR Part 19 (-6,588 hours for nuclear power reactor licensees [-
63.3 hours per licensee] and -4,294 hours for materials licensees [-1 
hour per licensee]); and a reduction of 9,969 hours total for NRC Form 
4 (-8,751 hours for nuclear power reactor licensees [-84 hours per 
licensee] and a reduction of 1,218 hours for materials licensees [-10 
hours per licensee]).
    Abstract: The U.S. Nuclear Regulatory Commission is proposing to 
revise several administrative requirements related to the reporting of 
dose to workers, the labeling of certain containers holding licensed 
material, and the determination of cumulative occupational radiation 
dose. The proposed rule would limit the routine reporting of annual 
doses to workers to those whose annual dose exceeds a specific dose 
threshold or who request a report. The proposed rule would also modify 
the labeling requirements for certain containers holding licensed 
material within posted areas in nuclear power facilities. The proposed 
rule would also remove 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 
would reduce the administrative and information collection burdens on 
licensees without affecting the level of protection to either the 
health and safety of workers and the public or the environment.
    The U.S. Nuclear Regulatory Commission is seeking public comment on 
the potential impact of the information collections contained in this 
proposed rule and on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    A copy of the OMB clearance package may be viewed free of charge at 
the NRC Public Document Room, One White Flint North, 11555 Rockville 
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and 
rule are available at the NRC worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the 
signature date of this notice and are also available at the rule forum 
site, http://ruleforum.llnl.gov.

[[Page 55390]]

    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by October 23, 2006 to the Records and FOIA/Privacy 
Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail to 
[email protected] and to the Desk Officer, John A. Asalone, Office 
of Information and Regulatory Affairs, NEOB-10202, (3150-0005, 3150-
0014, and 3150-0044), Office of Management and Budget, Washington, DC 
20503. Comments received after this date will be considered if it is 
practical to do so, but assurance of consideration cannot be given to 
comments received after this date. You may also e-mail comments to 
[email protected] or comment by telephone at (202) 395-
4650.

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.

XII. Regulatory Analysis

    The NRC has prepared a regulatory analysis on this proposed rule 
and has included it in this Federal Register notice. The analysis 
examines the costs and benefits of the alternatives considered by the 
NRC.

1. Statement of the Problem and Objective

    The NRC has determined that the regulations proposed for revision 
in 10 CFR 19.13, 20.1003, 20.1201, 20.1905, 20.2104, and 50.2 currently 
impose an undue regulatory burden on licensees. This proposed rule 
would amend certain requirements for notification of workers, revise 
the definition of total effective dose equivalent, amend certain 
container labeling requirements, and remove the requirement that 
licensees attempt to obtain the records of cumulative occupational 
radiation dose for certain individuals. These revisions are intended to 
reduce administrative and information collection burdens on NRC and 
Agreement State licensees without affecting the level of protection to 
either the health and safety of workers and the public or 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 retains the current regulations as 
described above in Section II. Licensees would continue to be required 
to: (1) Provide annual dose reports to all monitored individuals, (2) 
determine the total effective dose equivalent (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 proposed alternative. The 
no-action alternative would not accomplish the stated objective.
2.2 Proposed Rule Alternative
    Under the proposed rule alternative, the NRC would revise 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 would make the 
regulations consistent with current Commission policy and reduce 
administrative and information collection burdens on NRC and Agreement 
State licensees. Because this action was undertaken to ease burden, the 
rulemaking process is the only regulatory option appropriate to make 
the proposed changes effective.

3. Analysis of Values and Impacts of Proposed Rulemaking

3.1 Identification of Affected Attributes
    The attributes that the proposed 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 would be 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 the 
proposed changes, licensees would incur the costs of revising 
procedures.
    Industry Operation. This attribute would be affected by three of 
the four principal revisions. Licensees would 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 would incur costs to make minor 
revisions to NRC Form 3, ``Notice to Employees,'' to account for the 
proposed changes to the reporting of annual dose to workers. The NRC 
would also incur the costs of completing this regulatory action.
    Regulatory Efficiency. All four of the principal revisions would 
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 to either the 
health and safety of workers and the public or the environment.
3.2 Methodology
    The incremental savings and costs of the proposed regulatory action 
were 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 
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

[[Page 55391]]

submit annual reports using NRC Form 5, ``Occupational Dose Record for 
a Monitoring Period,'' or electronic media containing all the 
information required by NRC Form 5. For the above licensees, the value-
impact analysis uses the latest 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)). 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 be applicable to non-REIRS materials 
licensees.
    The following assumptions and data were used to assess the 
incremental values and impacts associated with the proposed 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.
     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. 
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 would require 
about 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 each of the proposed changes.
     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 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 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 proposed regulatory action, nuclear power 
reactor licensees would incur a one-time cost to revise procedures. The 
NRC estimates it would take 20 hours to revise the procedures for each 
of the 104 nuclear power plants. Assuming a staff rate of $100 per 
hour, the one-time cost of implementing the proposed action would be 
$2,000 per nuclear power plant (20 hours x $100/hour) and $210,000 for 
the nuclear power industry (104 licensees x $2,000/licensee).
    With respect to industry operation, there would 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). Based on 
public comment, the NRC estimates 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 discounted flow of funds at a 3 percent 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 discounted flow of funds at a 7 percent 
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.
    For this analysis, the NRC estimates it would 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 90 percent of this 
population would not request an annual dose report. Assuming an average 
of 1,060 workers per nuclear power plant, the annual burden reduction 
from implementing the proposed 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).

[[Page 55392]]

REIRS Materials Licensees
    In implementing the proposed regulatory action, REIRS materials 
licensees would incur a one-time cost to revise procedures. The NRC 
estimates it would take 10 hours to revise the procedures for each of 
the 123 REIRS materials licensees. Assuming a staff rate of $100 per 
hour, the one-time cost of implementing the proposed action would be 
$1,000 per licensee (10 hours x $100/hour) and $120,000 for all 
licensees in this category (123 licensees x $1,000/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 would not 
receive an annual dose report. It is further assumed that 90 percent of 
this population would 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 discounted flow of 
funds at a 3 percent 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 discounted flow of funds 
at a 7 percent rate, the estimated savings per licensee and for all 
licensees in this category are $6,000 ($670 x 10.6) and $780,000 
($74,000 x 10.6), respectively.
    For this analysis, the NRC estimates it would 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 would not 
request a dose report, the annual burden reduction from implementing 
the proposed 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 proposed regulatory action, non-REIRS materials 
licensees would incur a one-time cost to revise procedures. The NRC 
estimates it would take 10 hours to revise the procedures for each of 
the 21,692 non-REIRS materials licensees. Assuming a staff rate of $100 
per hour, the one-time cost of implementing the proposed action would 
be $1,000 per licensee (10 hours x $100/hour) and $22 million for all 
licensees in this category (21,692 licensees x $1,000/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 would not receive an annual dose report (NRC Form 5). Thus, 16 
workers per licensee are assumed not to receive an annual dose report. 
It is further assumed that 90 percent of this population would 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 discounted flow of funds at a 3 percent rate, the estimated savings 
per licensee and for all licensees in this category are $2,000 ($140 x 
14.9) and $44.7 million ($3 million x 14.9), respectively. For a 
discounted flow of funds at a 7 percent 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.
    For this analysis, the NRC estimates it would 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 would not 
request a dose report, the annual burden reduction from implementing 
the proposed 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 proposed revision to the 
definition of TEDE are minimal. The proposed revision would clarify 
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 would eliminate the need for 
licensees to repeatedly request guidance from the NRC and, in some 
cases, to request a license amendment to clarify the current 
definition.
3.3.3 Labeling Containers
    The proposed revision to 10 CFR 20.1905, ``Exemptions to labeling 
requirements,'' applies only to nuclear power reactor licensees. These 
licensees would incur one-time implementation costs to revise 
procedures. The NRC estimates it would take 20 hours to revise the 
procedures for each of the 104 nuclear power plants. Assuming a staff 
rate of $100 per hour, the one-time cost of implementing the proposed 
action would be $2,000 per licensee (20 hours x $100/hour) and $210,000 
for the nuclear power industry (104 licensees x $2,000/licensee).
    With respect to industry operation, based on public comments, the 
NRC estimates an annual savings of $30,000 per nuclear power plant if 
the proposed exemption to the labeling containers is granted. For the 
entire nuclear power industry, the NRC estimates a savings of $3.1 
million (104 licensees x $30,000/licensee). For a discounted flow of 
funds at a 3 percent 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 discounted 
flow of funds at a 7 percent 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.
    Using an annual savings of $30,000 per nuclear power plant and a 
staff rate of $100 per hour, the annual burden reduction from 
implementing the proposed action is estimated to be 300 hours per plant 
($30,000/licensee / $100/hour) and the total annual industry burden 
reduction is 31,000 hours (300 hours/licensee x 104 licensees).
3.3.4 Cumulative Occupational Radiation Dose
Nuclear Power Reactor Licensees
    In implementing the proposed regulatory action, nuclear power 
reactor licensees would incur a one-time cost to revise procedures. The 
NRC estimates it would take 20 hours to revise the procedures for each 
of the 104 nuclear power plants. Assuming a staff rate of $100 per 
hour, the one-time cost of implementing the proposed action would be 
$2,000 per nuclear power plant (20 hours x $100/hour) and $210,000 for 
the nuclear power industry (104 licensees x $2,000/licensee).
    With respect to industry operation, there would be a savings from 
not having to obtain the records of cumulative occupational radiation 
dose (NRC Form 4) for a worker, unless these

[[Page 55393]]

individuals are being authorized to receive a planned special exposure. 
Based on public comments, the NRC estimates the annual savings to be 
$8,500 per nuclear power plant and $880,000 for the nuclear power 
industry ($8,500 x 104 licensees). For a discounted flow of funds at a 
3 percent rate, the estimated savings per nuclear power plant and for 
the nuclear power industry are $220,000 ($8,500 x 25.50) and $22 
million ($880,000 x 25.50), respectively. For a discounted flow of 
funds at a 7 percent rate, the estimated savings per nuclear power 
plant and for the nuclear power industry are $120,000 ($8,500 x 13.77) 
and $12 million ($880,000 x 13.77), respectively.
    Using an annual savings of $8,500 per nuclear power plant and a 
staff rate of $100 per hour, the annual burden reduction from 
implementing the proposed action is estimated to be 85 hours per plant 
($8,500/licensee / $100/hour) and the total annual industry burden 
reduction is 8,800 hours (85 hours/licensee x 104 licensees).
REIRS Materials Licensees
    In implementing the proposed regulatory action, REIRS materials 
licensees would incur a one-time cost to revise procedures. The NRC 
estimates it would take 10 hours to revise the procedures for each of 
the 123 REIRS materials licensees. Assuming a staff rate of $100 per 
hour, the one-time cost of implementing the proposed action would be 
$1,000 per licensee (10 hours x $100/hour) and $120,000 for all 
licensees in this category (123 licensees x $1,000/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 would be 
affected and that 0.5 hour is required to complete, review, and 
authorize each NRC Form 4, ``Cumulative Occupational Dose History.'' 
Using a staff rate of $100 per hour, the estimated savings is $50 per 
worker ($100/hour x 0.5 hour) by not being required to complete NRC 
Form 4. 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 would not be needed as the basis for 
authorizing a planned special exposure. Thus, the estimated annual 
savings is $970 per licensee (98 workers/licensee x $50/worker x 0.2 x 
.99) and $120,000 for all licensees in this category ($970/licensee x 
123 licensees). For a discounted flow of funds at a 3 percent rate, the 
estimated savings per licensee and for all licensees in this category 
are $14,000 ($970 x 14.9) and $1.8 million ($120,000 x 14.9), 
respectively. For a discounted flow of funds at a 7 percent rate, the 
estimated savings per licensee and for all licensees in this category 
are $10,000 ($980 x 10.6) and $1.3 million ($120,000 x 10.6), 
respectively.
    The annual burden reduction from implementing the proposed action 
is estimated to be 10 hours per licensee (98 workers/licensee x 0.5 
hour/worker x 0.2 x 0.99) and 1,200 hours for all licensees in this 
category (10 hours/licensee x 123 licensees).
Non-REIRS Materials Licensees
    In implementing the proposed regulatory action, non-REIRS materials 
licensees would incur a one-time cost to revise procedures. The NRC 
estimates it would take 10 hours to revise the procedures for each of 
the 21,692 non-REIRS materials licensees. Assuming a staff rate of $100 
per hour, the one-time cost of implementing the proposed action would 
be $1,000 per licensee (10 hours x $100/hour) and $22 million for all 
licensees in this category (21,692 licensees x $1,000/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 would be affected and that 
0.5 hour is required to complete, review, and authorize each NRC Form 
4. Using a staff rate of $100 per hour, the estimated savings is $50 
per worker ($100/hour x 0.5 hour) by not being required to complete NRC 
Form 4. 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 would not be needed as the basis for 
authorizing a planned special exposure. Thus, the estimated annual 
savings is $230 per licensee (23 workers/licensee x $50/worker x 0.2 x 
0.99) and $5 million for all licensees in this category ($230/licensee 
x 21,692 licensees). For a discounted flow of funds at a 3 percent 
rate, the estimated savings per licensee and for all licensees in this 
category are $3,400 ($230 x 14.9) and $75 million ($5 million x 14.9), 
respectively. For a discounted flow of funds at a 7 percent rate, the 
estimated savings per licensee and for all licensees in this category 
are $2,400 ($230 x 10.6) and $53 million ($5 million x 10.6), 
respectively.
    Using an annual savings of $230 per licensee and a staff rate of 
$100 per hour, the annual burden reduction from implementing the 
proposed action is estimated to be 2.3 hours per licensee ($230/
licensee / $100/hour) and 50,000 hours for all licensees in this 
category (2.3 hours/licensee x 21,692 licensees). For NRC licensees 
only, the total annual burden reduction is estimated to be 10,100 hours 
(2.3 hours/licensee x 4,394 NRC licensees).
3.3.5 NRC Implementation and Operating Impacts
Annual Dose Report to Workers
    The NRC would incur costs to make minor revisions to NRC Form 3, 
``Notice to Employees,'' to account for the proposed 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 $28,000 (320 staff-hours at $88 
per hour). This is the only impact to the NRC for the proposed action.
Definition of Total Effective Dose Equivalent (TEDE)
    The NRC would incur no implementation or operating impacts due to 
the proposed revision to the definition of TEDE.
Labeling Containers
    The NRC would incur no implementation or operating impacts due to 
the proposed revision to the labeling of containers holding licensed 
material.
Cumulative Occupational Radiation Dose
    The NRC would incur no implementation impacts due to the proposed 
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 would 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 $88 per hour, the estimated 
annual savings to the NRC is $9,200 (1 hour x 104 licensees x $88/
hour). For a discounted flow of funds at a 3 and 7 percent rate, the 
estimated savings to the NRC are $235,000 ($9,200 x 25.50)

[[Page 55394]]

and $130,000 ($9,200 x 13.77), respectively.
    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 would not 
need to be inspected as the basis for authorizing a planned special 
exposure. Assuming an NRC staff rate of $88 per hour, the estimated 
annual savings to the NRC is $1,100 (0.1 hour x 123 licensees x $88/
hour x 0.99). For a discounted flow of funds at a 3 and 7 percent rate, 
the estimated savings to the NRC are $16,000 ($1,100 x 14.9) and 
$12,000 ($1,100 x 10.6), respectively.
    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 would not need to be inspected as the basis for 
authorizing a planned special exposure. Assuming an NRC staff rate of 
$88 per hour, the estimated annual savings to the NRC is $38,000 (0.1 
hour x 4,394 licensees x $88/hour x 0.99). For a discounted flow of 
funds at a 3 and 7 percent rate, the estimated savings to the NRC are 
$570,000 ($38,000 x 14.9) and $400,000 ($38,000 x 10.6), respectively.
Cost of the Regulatory Action
    The NRC would incur 0.8 full time equivalent (FTE) of staff time to 
complete this rulemaking after publishing the proposed rule. The cost 
for this action is estimated to be $126,000 (0.8 FTE at $157,000 per 
FTE).
3.3.6 Other Government Implementation and Operating Impacts
    The Agreement States would incur no implementation or operating 
impacts due to the proposed revisions to the reporting of annual dose 
to workers, the definition of TEDE, or the labeling of containers 
holding licensed material.
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 would not need to be inspected as the basis for 
authorizing a planned special exposure. Assuming an Agreement State 
staff rate of $88 per hour, the estimated annual savings to the 
Agreement States is $150,000 (0.1 hour x 17,298 licensees x $88/hour x 
0.99). For a discounted flow of funds at a 3 and 7 percent rate, the 
estimated savings to the Agreement States are $2.2 million ($150,000 x 
14.9) and $1.6 million ($150,000 x 10.6), respectively. The annual 
burden reduction to the Agreement States from implementing the proposed 
action is estimated to be 1,700 hours (0.1 hour x 17,298 licensees x 
0.99).
    The annual burden reduction to the Agreement States from 
implementing the proposed action is estimated to be 1,700 hours (0.1 
hour x 17,298 licensees x 0.99).

4. Presentation of Results

    The results of the NRC's value-impact assessment for industry 
implementation and operation are summarized in the following table.

                   Table 1.--Summary of Industry Implementation and Operating Savings (Costs)
----------------------------------------------------------------------------------------------------------------
                                                                                 Operating savings (costs)
                                                        Implementation   ---------------------------------------
   Proposed regulatory action      Licensee category    savings (costs)     Using 7 percent     Using 3 percent
                                                           ($1,000)          discount rate       discount rate
                                                                               ($1,000)            ($1,000)
----------------------------------------------------------------------------------------------------------------
Annual dose report to workers...  Nuclear power                    (210)              4,300               8,000
                                   reactor.
                                  REIRS materials...               (120)                780               1,100
                                  Non-REIRS                     (22,000)             32,000              45,000
                                   materials.
TEDE............................  Nuclear power                     N/A                (\1\)               (\1\)
                                   reactor.
                                  REIRS materials...                N/A                (\1\)               (\1\)
                                  Non-REIRS                         N/A                (\1\)               (\1\)
                                   materials.
Labeling containers.............  Nuclear power                    (210)             43,000              79,000
                                   reactor.
                                  REIRS materials...                N/A                 N/A                 N/A
                                  Non-REIRS                         N/A                 N/A                 N/A
                                   materials.
Cumulative occupational           Nuclear power                    (210)             12,000              22,000
 radiation dose.                   reactor.
                                  REIRS materials...               (120)              1,300               1,800
                                  Non-REIRS                     (22,000)             53,000              75,000
                                   materials.
                                                     -----------------------------------------------------------
    Subtotals...................  Nuclear power                    (630)             59,300             109,000
                                   reactor.
                                  REIRS materials...               (240)              2,080               2,900
                                  Non-REIRS                     (44,000)             85,000             120,000
                                   materials.
                                                     -----------------------------------------------------------
        Total (rounded).........  ..................            (45,000)            146,000             232,000
----------------------------------------------------------------------------------------------------------------
\1\Minimal.

    The results of the NRC's value-impact assessment for NRC 
implementation and operation are summarized in the following table.

[[Page 55395]]



                      Table 2.--Summary of NRC Implementation and Operating Savings (Costs)
----------------------------------------------------------------------------------------------------------------
                                                                                  Operating savings (costs)
                                                          Implementation   -------------------------------------
    Proposed regulatory action      Licensee category     savings (costs)    Using 7 percent    Using 3 percent
                                                             ($1,000)         discount rate      discount rate
                                                                                 ($1,000)           ($1,000)
----------------------------------------------------------------------------------------------------------------
Annual dose report to workers....  Nuclear power        ..................  .................  .................
                                    reactor.
                                   REIRS materials....                (28)                N/A                N/A
                                   Non-REIRS materials  ..................  .................  .................
TEDE.............................  Nuclear power        ..................  .................  .................
                                    reactor.
                                   REIRS materials....                N/A                 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  Nuclear power                                          130                235
 dose.                              reactor.
                                   REIRS materials....                N/A                  12                 16
                                   Non-REIRS materials                                    570                400
Cost of the regulatory action....  ...................               (126)                N/A                N/A
                                                       ---------------------------------------------------------
    Total (rounded)..............  ...................               (154)                710                650
----------------------------------------------------------------------------------------------------------------

    The results of the NRC's value-impact assessment for Agreement 
States implementation and operation are summarized in the following 
table.

               Table 3.--Summary of Agreement States Implementation and Operating Savings (Costs)
----------------------------------------------------------------------------------------------------------------
                                                                                  Operating savings (costs)
                                                           Implementation  -------------------------------------
               Proposed regulatory action                 savings (costs)    Using 7 percent    Using 3 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              1,600              2,200
                                                        --------------------------------------------------------
    Total (rounded)....................................                N/A              1,600              2,200
----------------------------------------------------------------------------------------------------------------

    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)
        Proposed 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........               300               31,000
                                            REIRS materials..............               N/A                  N/A
                                            Non-REIRS materials..........               N/A                  N/A
Cumulative occupational radiation dose....  Nuclear power reactor........                85                8,800
                                            REIRS materials..............                10                1,200
                                            Non-REIRS materials..........                 2.3             50,000
                                                                          --------------------------------------
    Subtotals.............................  Nuclear power reactor........               448               46,400
                                            REIRS materials..............                15                1,820
                                            Non-REIRS materials..........                 3.5             76,000
                                                                          --------------------------------------
        Total (rounded)...................  .............................               500              124,000
----------------------------------------------------------------------------------------------------------------


[[Page 55396]]

    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)
    Proposed regulatory action     -------------------------------------
                                           NRC          Agreement states
------------------------------------------------------------------------
Annual dose report to workers.....                N/A                N/A
TEDE..............................                N/A                N/A
Labeling containers...............                N/A                N/A
Cumulative occupational radiation                 555              1,700
 dose.............................
                                   --------------------
    Total.........................                555              1,700
------------------------------------------------------------------------

    The total implementation cost to the NRC for the proposed 
regulatory action is $154,000. The total operating impact to the NRC 
for a discounted flow of funds at a 3 and 7 percent rate is an 
estimated savings of $650,000 and $710,000, respectively.
    There are no implementation impacts to the Agreement States for the 
proposed regulatory action. The total operating impact to the Agreement 
States for a discounted flow of funds at a 3 and 7 percent rate is an 
estimated savings of $1.6 million and $2.2 million, respectively.
    The net present value of the proposed action is $197 million at a 3 
percent discount rate [industry operation ($239 million) + NRC 
operation ($650,000) + Agreement State Operation (2.2 million)] - [NRC 
implementation ($154,000) + industry implementation ($45 million)]. The 
net present value of the proposed action is $103 million at a 7 percent 
discount rate [industry operation ($146 million) + NRC operation 
($710,000) + Agreement State Operation (1.6 million)] - [NRC 
implementation ($154,000) + industry implementation ($45 million)].
    The total reduction in annual burden from implementing the proposed 
action is estimated to be 126,000 hours [industry (124,000 hours) + NRC 
(555 hours) + Agreement States (1,700 hours)].
    Several comments were received on the costs and benefits of the 
draft rule language (69 FR 8350; February 24, 2004) and are included 
above in Section III. These comments were considered in the development 
of this regulatory analysis.

5. Decision Rationale

    The net present value of this proposed action is $197 million and 
$103 million for 3 and 7 percent discount rates, respectively. The 
total industry reduction in annual burden from implementing the 
proposed action is estimated to be 126,000 hours. These savings are 
obtained by reducing administrative and information collection 
requirements on licensees. The NRC recommends proceeding with the 
proposed rule because the changes improve the effectiveness of NRC 
regulations and reduce unnecessary regulatory burden without affecting 
the level of protection to either the health and safety of workers and 
the public or the environment.

6. Implementation Schedule

    After the publication of the proposed rule in the Federal Register 
and the consideration and resolution of the public comments, a final 
rule would be published, that would become effective 30 days after 
publication.
    The Commission requests public comments on the draft regulatory 
analysis. Comments on the draft analysis may be submitted to the NRC as 
indicated under the ADDRESSES heading.

XIII. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the Commission certifies that this proposed rule, if adopted, 
would 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 
proposed rule pertain to all 21,692 licensees regulated by the NRC and 
Agreement States, licensees, including the affected small entities, 
could continue their current practices and remain in compliance with 
the proposed regulation. Licensees would be expected to incur the costs 
of changing their procedures only if they determine that the changes 
are cost effective, therefore, the NRC has determined that the changes 
would not have a significant economic impact on licensees defined as 
small entities. The change related to labeling containers would affect 
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.

XIV. Backfit Analysis

    The NRC has determined that the backfit rule does not apply to this 
proposed rule and that a backfit analysis is not required for this 
proposed rule because these amendments do not involve any provisions 
that would impose backfits as defined in 10 CFR Chapter I.

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.
    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

[[Page 55397]]

amendments to 10 CFR parts 19, 20, and 50.

PART 19--NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION 
AND INVESTIGATIONS

    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).

    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

    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).

    4. In Sec.  20.1003, the definition of Total Effective Dose 
Equivalent is revised to read as follows:


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).
* * * * *
    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 devise, 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.
* * * * *
    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 instructions 
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.
    7. In Sec.  20.2104, the introductory text of paragraphs (a) and 
(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.
---------------------------------------------------------------------------

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

* * * * *
    8. Section 20.2205 is revised to read as follows:


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 the 
Commission. This report must be transmitted no later than the 
transmittal to the Commission.

[[Page 55398]]

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION 
FACILITIES

    9. The authority citation for part 50 continues to read as follows:

    Authority: Secs. 102, 103, 104, 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).

    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).
    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 13th day of September, 2006.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary for the Commission.
 [FR Doc. E6-15502 Filed 9-21-06; 8:45 am]
BILLING CODE 7590-01-P