[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