Individual Monitoring Devices, 15347-15352 [2020-05295]
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15347
Rules and Regulations
Federal Register
Vol. 85, No. 53
Wednesday, March 18, 2020
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.
NUCLEAR REGULATORY
COMMISSION
10 CFR Parts 34, 36, and 39
[NRC–2019–0031]
RIN 3150–AK29
Individual Monitoring Devices
Nuclear Regulatory
Commission.
ACTION: Direct final rule.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is amending its
regulations to authorize the use of
modern individual monitoring devices
in industrial radiographic, irradiator,
and well logging operations. These
amendments will align personnel
dosimetry requirements in these areas
with the requirements for all other NRC
licensees. This direct final rule
addresses an issue raised in a petition
for rulemaking and will affect NRC and
Agreement State licensees. The NRC
also is issuing supplemental guidance
for use and comment with this direct
final rule.
DATES: This direct final rule and
supplemental guidance are effective
June 16, 2020. If adverse comments on
the direct final rule are received by
April 17, 2020 the direct final rule will
be withdrawn. If the direct final rule is
withdrawn, the supplemental guidance
also is withdrawn; timely notice of the
withdrawal will be published in the
Federal Register. Comments received
after this date will be considered if it is
practical to do so, but the NRC is able
to ensure consideration only for
comments received on or before this
date. If the direct final rule is
withdrawn, comments will be addressed
in a subsequent final rule. Comments
received on this direct final rule and
supplemental guidance will also be
considered as comments on the
companion proposed rule published in
the Proposed Rules section of this issue
of the Federal Register.
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SUMMARY:
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You may submit comments
by any of the following methods:
• Federal Rulemaking website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2019–0031. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. For
technical questions contact the
individuals listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Email comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
• Fax comments to: Secretary, U.S.
Nuclear Regulatory Commission at 301–
415–1101.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
• Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
(Eastern Time) Federal workdays;
telephone: 301–415–1677.
For additional direction on obtaining
information and submitting comments,
see ‘‘Obtaining Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Anthony McMurtray, telephone: 301–
415–2746; email: Anthony.McMurtray@
nrc.gov; or Edward Lohr, telephone:
301–415–0253; email: Edward.Lohr@
nrc.gov. Both are staff of the Office of
Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Table of Contents
I. Obtaining Information and Submitting
Comments
II. Rulemaking Procedure
III. Background
IV. Discussion
V. Guidance Documents
VI. Section-by-Section Analysis
VII. Regulatory Analysis
VIII. Regulatory Flexibility Certification
IX. Backfitting and Issue Finality
X. Plain Writing
XI. National Environmental Policy Act
XII. Paperwork Reduction Act Statement
XIII. Congressional Review Act
XIV. Compatibility of Agreement State
Regulations
XV. Voluntary Consensus Standards
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I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2019–
0031 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2019–0031.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘Begin Web-based ADAMS Search.’’ For
problems with ADAMS, please contact
the NRC’s Public Document Room (PDR)
reference staff at 1–800–397–4209, 301–
415–4737, or by email to pdr.resource@
nrc.gov. The ADAMS accession number
for each document referenced (if it is
available in ADAMS) is provided the
first time that it is mentioned in this
document.
• NRC’s PDR: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC–2019–
0031 in your comment submission.
The NRC cautions you not to include
identifying or contact information that
you do not want to be publicly
disclosed in your comment submission.
The NRC will post all comment
submissions at https://
www.regulations.gov as well as enter the
comment submissions into ADAMS.
The NRC does not routinely edit
comment submissions to remove
identifying or contact information.
If you are requesting or aggregating
comments from other persons for
submission to the NRC, then you should
inform those persons not to include
identifying or contact information that
they do not want to be publicly
disclosed in their comment submission.
Your request should state that the NRC
does not routinely edit comment
submissions to remove such information
before making the comment
submissions available to the public or
entering the comment into ADAMS.
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II. Rulemaking Procedure
Because the NRC considers this action
to be non-controversial, the NRC is
using the direct final rule procedure for
this rule. The amendment to the rule
will become effective on June 16, 2020.
However, if the NRC receives significant
adverse comments on this direct final
rule by April 17, 2020, then the NRC
will publish a document that withdraws
this direct final rule, as well as the
associated supplemental guidance. In
such a case, the NRC will treat
comments on this direct final rule as
comments on the companion proposed
rule published in the Proposed Rules
section of this issue of the Federal
Register. Absent significant
modifications to the proposed revisions
requiring republication, the NRC will
not initiate a second comment period on
this action.
A significant adverse comment is a
comment where the commenter
explains why the rule would be
inappropriate, including challenges to
the rule’s underlying premise or
approach, or would be ineffective or
unacceptable without a change. A
comment is adverse and significant if:
(1) The comment opposes the rule and
provides a reason sufficient to require a
substantive response in a notice-andcomment process. For example, a
substantive response is required when:
(a) The comment causes the NRC to
reevaluate (or reconsider) its position or
conduct additional analysis;
(b) The comment raises an issue
serious enough to warrant a substantive
response to clarify or complete the
record; or
(c) The comment raises a relevant
issue that was not previously addressed
or considered by the NRC.
(2) The comment proposes a change
or an addition to the rule, and it is
apparent that the rule would be
ineffective or unacceptable without
incorporation of the change or addition.
(3) The comment causes the NRC to
make a change (other than editorial) to
the rule.
For detailed instructions on filing
comments, please see the ADDRESSES
section of this document.
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III. Background
The regulations in part 34 of title 10
of the Code of Federal Regulations (10
CFR), ‘‘Licenses for Industrial
Radiography and Radiation Safety
Requirements for Industrial
Radiographic Operations’’; 10 CFR part
36, ‘‘Licenses and Radiation Safety
Requirements for Irradiators’’; and 10
CFR part 39, ‘‘Licenses and Radiation
Safety Requirements for Well Logging,’’
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require the use of personnel dosimetry
that is processed and evaluated by an
accredited National Voluntary
Laboratory Accreditation Program
(NVLAP) processor. These regulations
restrict the types of personnel
dosimeters that can be used and
prohibit the use of dosimetry
technologies that do not require
processing by an accredited NVLAP
facility.
On July 14, 2016, the NRC received a
petition for rulemaking (PRM) from the
American Society for Nondestructive
Testing and the Nondestructive Testing
Management Association (the
petitioners) (ADAMS Accession No.
ML16228A045). The petition was
docketed by the NRC on August 12,
2016, and assigned Docket No. PRM–
34–7. The NRC published a notice of
docketing of PRM–34–7 in the Federal
Register (81 FR 78732) on November 9,
2016. The petitioners requested that the
NRC amend its regulations and
associated guidance to authorize the use
of improved individual monitoring
devices for industrial radiographic
personnel. Specifically, the petitioners
requested that the NRC amend its
regulations to authorize the use of
digital output personnel dosimeters to
satisfy the personnel dosimetry
requirements in § 34.47(a).
Personnel dosimetry is a specific type
of dosimetry that is used to track an
individual worker’s dose. The
petitioners interchangeably used the
terms ‘‘improved individual monitoring
devices,’’ ‘‘electronic personnel
monitoring dosimeters,’’ ‘‘electronic
dosimeters,’’ and ‘‘digital personnel
dosimeters’’ to describe digital output
personnel dosimetry. In this direct final
rule, the NRC uses the term ‘‘digital
output personnel dosimetry’’ in place of
these terms. A digital output personnel
dosimeter is a specific type of personnel
dosimetry that currently cannot be used
to meet the requirements in 10 CFR
parts 34, 36, and 39 to demonstrate
compliance with the occupational dose
limits in § 20.1201.
On February 11, 2019, the NRC
published a document in the Federal
Register (84 FR 3116) informing the
public that it would consider PRM–34–
7 in the rulemaking process. In the
Federal Register document, the NRC
accepted the petitioners’ request that the
NRC amend its regulations to authorize
the use of digital output personnel
dosimeters for industrial radiographic
personnel and expanded the scope of
the rulemaking to include the use of
digital output personnel dosimeters in
irradiator and well logging operations.
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IV. Discussion
The NRC’s requirements related to the
safe use of sealed sources of byproduct
material in industrial radiography are
codified in 10 CFR part 34. The
regulation in § 34.47(a) states that
during radiographic operations,
radiographers and radiographer’s
assistants must wear ‘‘a direct reading
dosimeter, an operating alarm ratemeter,
and a personnel dosimeter that is
processed and evaluated by an
accredited National Voluntary
Laboratory Accreditation Program
(NVLAP) processor.’’
Although ‘‘processing’’ is not defined
in the regulations, the NRC uses it with
a specific meaning related to personnel
dosimetry. The NRC interprets
processing to mean a process, separate
from and independent of the design of
the dosimeter, that is required to extract
dose information from the dosimeter
after exposure to radiation. Processing is
necessary with film, thermoluminescent
dosimetry (TLD), and optically
stimulated luminescence (OSL)
dosimetry to obtain the dose
information. With film, TLD, and OSL
dosimetry, the quality of the processing
is dependent on the competence of the
processor and not on the dosimeter
design, whereas quality is built into the
design of dosimeters that do not require
processing. An in-depth discussion on
this topic can be found in the January
14, 2005, Federal Register document (70
FR 2577) denying a petition for
rulemaking (PRM–20–25).
Film, TLD, and OSL dosimeters are
examples of devices that require
processing by qualified technicians
using separate equipment to obtain data
that is used to compute the dose
measurement. Therefore, these types of
dosimeters must be processed by an
accredited NVLAP facility to ensure the
quality of the processing. The NVLAP
does not certify or accredit dosimetry
devices themselves; it only certifies or
accredits device processing.
Accreditation by the NVLAP provides a
level of assurance of quality of the
measurement (i.e., accuracy, precision,
and reliability) for processors.
Some recently designed personnel
dosimeters do not require the type of
processing envisioned in the text of
§ 34.47(a)—that is, data extraction
through a process independent of the
dosimeter. For example, some personnel
dosimeters can provide instantaneous
dose readings using internet-enabled
computers, smartphones, and tablets.
Data is extracted from the detector and
then digitally transferred from the
dosimeter for computation. The design
of the personnel dosimeter, rather than
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the training and qualifications of the
processing technician, ensures accurate
dose information from the dosimeter
after exposure to radiation.
Current regulations in § 34.47(a) and
similar provisions in 10 CFR parts 36
and 39 require use of personnel
dosimeters that require processing. This
direct final rule eliminates these
requirements for personnel dosimeters
that require processing. The
requirements in 10 CFR part 20 will
continue to provide standards for the
use of all personnel dosimeters.
The NRC considered recent peerreviewed literature and NRC documents
on the performance of digital output
personnel dosimeters that were
authorized by Agreement State and NRC
licensees. The NRC determined that
digital output personnel dosimetry has
been used successfully by NRC
licensees in other operational settings,
by some Agreement State licensees in
all areas—including industrial
radiography, and internationally in
multiple applications. The NRC did not
find any evidence of generic
performance problems with digital
output personnel dosimetry in other
operating settings, nor did the NRC
identify any adverse trends that would
preclude the use of this dosimetry by all
NRC licensees.
In addition, the NRC evaluated the
technical specifications of currently
available digital output personnel
dosimetry and determined that they met
or exceeded performance standards,
operability criteria (e.g., temperature,
humidity), dose ranges, and quality
control expectations for use in
industrial radiographic, irradiator, and
well logging operations. The NRC did
not identify issues that would preclude
the use of digital output personnel
dosimetry in industrial radiographic,
irradiator, or well logging operations.
Therefore, the NRC determined that
there is no technical basis for
continuing to limit the types of
personnel dosimeters used in industrial
radiography, irradiator, and well logging
operations to only those that are
processed and evaluated by an
accredited NVLAP processor. The levels
and types of radiation fields
encountered in these operations are also
encountered in other industries where
digital output personnel dosimeters
already are allowed. The NRC
determined that mandating the use of a
particular type of personnel dosimetry
will not prevent or reduce the dose
received or result in more accurate,
precise, or reliable measurements.
In addition, having access to digital
output personnel dosimeters is
especially beneficial to industrial
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radiography licensees. Under § 34.47(d),
certain circumstances require workers to
cease work immediately until their
radiation dose has been determined.
This can involve three or more days of
wait time while the personnel dosimeter
is sent off-site for processing and
evaluation, which could cost the
licensee revenue and lost time. Workers
using digital output personnel
dosimeters do not need to send their
dosimeters to a processor and can have
their radiation dose determined locally
so that the issue can be resolved
quickly.
Consistent with the agency’s focus on
implementing risk-informed,
performance-based regulations and
transforming its regulatory approaches,
the NRC is amending the requirements
for licensees under 10 CFR parts 34, 36,
and 39 to enable the use of any
personnel dosimeters. Removing the
requirement to use personnel
dosimeters that are processed and
evaluated by an accredited NVLAP
facility will allow the use of digital
output personnel dosimeters (which do
not require processing) and ensure all
NRC licensees are held to the same
standards for personnel dosimetry. Also,
because the current regulations are
based on the use of film, TLD, and OSL
dosimeters (all of which require
processing by an accredited NVLAP
processor), conforming and clarifying
changes related to exchange intervals,
monitoring, and recordkeeping are being
made to 10 CFR parts 34, 36, and 39 to
address personnel dosimeters that do
not require processing. These
amendments will allow greater
consistency with the Agreement States’
programs.
On May 11, 2018, the NRC issued an
Enforcement Guidance Memorandum
(EGM–18–001) that provides guidance
for dispositioning potential violations of
NRC requirements for personnel
dosimetry during NRC-licensed
activities under 10 CFR parts 34, 36, and
39 (ADAMS Accession No.
ML18068A623). In the EGM, the NRC
stated that industrial radiographic,
irradiator, and well logging licensees
who use digital output personnel
dosimetry for personnel monitoring (i.e.,
dosimetry used for the dose of record)
would not be subject to enforcement
action for some potential violations of
NRC requirements associated with the
use of these dosimeters provided that
specified conditions are met. The NRC
considered the specific conditions
specified in EGM–18–001 during the
development of this direct final rule.
The EGM will expire when this direct
final rule becomes effective.
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V. Guidance Documents
The NRC is issuing supplemental
guidance in conjunction with this direct
final rule. Guidance on 10 CFR parts 34,
36, and 39 is provided in NUREG–1556,
‘‘Consolidated Guidance About
Materials Licenses,’’ in the volumes for
industrial radiography (Volume 2),
irradiators (Volume 6), and well logging
(Volume 14). This supplemental
guidance is intended for use by
applicants, licensees, Agreement States,
and the NRC staff when personnel
dosimeters that do not require
processing are being used. It includes
guidance to applicants for the
completion and submission of materials
license applications to the NRC and
model procedures that an applicant or
licensee may consider when developing
or changing its radiation safety program.
The supplemental guidance
documents (ADAMS package Accession
No. ML19360A184) are in a markup
format to NRC’s existing guidance and
reflect the provisions in the direct final
rule. On the effective date of the direct
final rule, licensees that elect to use
personnel dosimeters that do not require
processing may use the supplemental
guidance to comply with the provisions
in the direct final rule.
Comments on the supplemental
guidance may be submitted as directed
in Section I, ‘‘Obtaining Information and
Submitting Comments,’’ of this
document. The NRC will incorporate
this supplemental guidance into the
next comprehensive revision of
NUREG–1556.
VI. Section-by-Section Analysis
The following paragraphs describe the
specific changes made in this direct
final rule.
Section 34.47
Personnel Monitoring
In § 34.47, this direct final rule revises
paragraph (a) by removing the
requirement to use a personnel
dosimeter that is processed and
evaluated by an accredited NVLAP
processer, revises paragraph (a)(3) to
make conforming changes, and removes
paragraph (a)(4).
Paragraph (d) is revised to include the
requirement to begin evaluating an
individual’s personnel dosimeter within
24 hours for personnel dosimeters that
do not require processing, if the
conditions in the paragraph are met.
Paragraph (f) is revised to state that all
dosimetry results received by a licensee
are to be retained in accordance with
§ 34.83.
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Section 34.83 Records of Personnel
Monitoring Procedures
In § 34.83, this direct final rule revises
paragraph (c) by removing the phrase
‘‘received from the accredited NVLAP
processor.’’
Section 36.55 Personnel Monitoring
In § 36.55, this direct final rule revises
paragraph (a) by removing the
requirement to use a personnel
dosimeter that is processed and
evaluated by an accredited NVLAP
processer and clarifying that all
personnel dosimeters must be capable of
detecting high energy photons in the
normal and accident dose ranges. The
reference to § 20.1501(c) is removed
because it does not apply to all
personnel dosimetry. Conforming
changes are made to clarify that
personnel dosimeters that require
processing must be replaced at
appropriate intervals, that all personnel
dosimeters must be evaluated promptly
after replacement and at least quarterly,
and an individual’s radiation dose must
be determined at periods not to exceed
three months.
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Section 39.65 Personnel Monitoring
In § 39.65, this direct final rule revises
paragraph (a) by removing the
requirement to use a personnel
dosimeter that is processed and
evaluated by an accredited NVLAP
processer. Conforming changes are
made to clarify that personnel
dosimeters that require processing must
be replaced at appropriate intervals, that
all personnel dosimeters must be
evaluated promptly after replacement
and at least quarterly, and an
individual’s radiation dose must be
determined at periods not to exceed
three months.
regulatory analysis, these amendments
do not have a significant economic
impact on the affected small entities.
IX. Backfitting and Issue Finality
The revisions to 10 CFR parts 34, 36,
and 39 would not constitute backfitting
as these parts do not have a backfitting
provision. In addition, the revisions
would not impose any additional
requirements. Personnel dosimeters that
are not processed would be authorized
for voluntary use by licensees, but not
required.
X. Plain Writing
The Plain Writing Act of 2010 (Pub.
L. 111–274) requires Federal agencies to
write documents in a clear, concise, and
well-organized manner. The NRC has
written this document to be consistent
with the Plain Writing Act as well as the
Presidential Memorandum, ‘‘Plain
Language in Government Writing,’’
published June 10, 1998 (63 FR 31885).
XI. National Environmental Policy Act
The NRC has determined that this
direct final rule is the type of action
described in § 51.22(c)(2). Therefore,
neither an environmental impact
statement nor environmental assessment
has been prepared for this direct final
rule.
XII. Paperwork Reduction Act
This direct final rule does not contain
any new or amended collections of
information subject to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). Existing collections of
information were approved by the
Office of Management and Budget,
approval numbers 3150–0007, 3150–
0130, and 3150–0158.
Public Protection Notification
VII. Regulatory Analysis
The NRC has prepared a regulatory
analysis (ADAMS Accession No.
ML19283B555) to support this direct
final rule. The analysis examines the
costs and benefits of the alternatives
considered by the NRC.
The NRC may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless the
document requesting or requiring the
collection displays a currently valid
OMB control number.
VIII. Regulatory Flexibility
Certification
Under the Regulatory Flexibility Act
(5 U.S.C. 605(b)), the NRC certifies that
this direct final rule will not, if issued,
have a significant economic impact on
a substantial number of small entities.
This direct final rule affects a number of
‘‘small entities’’ as defined by the
Regulatory Flexibility Act or the size
standards established by the NRC
(§ 2.810). However, as indicated in the
This direct final rule is a rule as
defined in the Congressional Review
Act (5 U.S.C. 801–808). However, the
Office of Management and Budget has
not found it to be a major rule as
defined in the Congressional Review
Act.
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XIII. Congressional Review Act
XIV. Compatibility of Agreement State
Regulations
Under the ‘‘Agreement State Program
Policy Statement’’ approved by the
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Commission on October 2, 2017 and
published in the Federal Register on
October 18, 2017 (82 FR 48535), the
NRC program elements (including
regulations) are placed into
Compatibility Categories A, B, C, D,
NRC, or Adequacy Category Health and
Safety (H&S). Compatibility Category A
are those program elements that are
basic radiation protection standards and
scientific terms and definitions that are
necessary to understand radiation
protection concepts. An Agreement
State should adopt Category A program
elements in an essentially identical
manner in order to provide uniformity
in the regulation of agreement material
on a nationwide basis. Compatibility
Category B are those program elements
that apply to activities that have direct
and significant effects in multiple
jurisdictions. An Agreement State
should adopt Category B program
elements in an essentially identical
manner. Compatibility Category C are
those program elements that do not
meet the criteria of Category A or B, but
the essential objectives of which an
Agreement State should adopt to avoid
conflict, duplication, gaps, or other
conditions that would jeopardize an
orderly pattern in the regulation of
agreement material on a national basis.
An Agreement State should adopt the
essential objectives of the Category C
program elements. Compatibility
Category D are those program elements
that do not meet any of the criteria of
Category A, B, or C, and thus, do not
need to be adopted by Agreement States
for purposes of compatibility.
Compatibility Category NRC are those
program elements that address areas of
regulation that cannot be relinquished
to the Agreement States under the
Atomic Energy Act of 1954, as amended,
or provisions of title 10 of the Code of
Federal Regulations. These program
elements should not be adopted by the
Agreement States. Compatibility
Category H&S are program elements that
are required because of a particular
health and safety role in the regulation
of agreement material within the State
and should be adopted in a manner that
embodies the essential objectives of the
NRC program.
This direct final rule is a matter of
compatibility between the NRC and the
Agreement States, thereby providing
consistency among Agreement State and
the NRC requirements. The
compatibility categories are designated
in the following table:
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COMPATIBILITY TABLE
Compatibility
Section
Change
Subject
Existing
Part 34:
34.47(a) ....................
34.47(a)(3) ................
34.47(d) ....................
34.47(f) .....................
34.83(c) .....................
Part 36:
36.55(a) ....................
Part 39:
39.65(a) ....................
Amend
Amend
Amend
Amend
Amend
......................
......................
......................
......................
......................
C
C
C
C
C
............
............
............
............
............
C
C
C
C
C
Personnel monitoring ................................................................................
H&S .......
H&S
Amend ......................
Personnel monitoring devices ...................................................................
C ............
C
List of Subjects
10 CFR Part 34
Criminal penalties, Manpower
training programs, Occupational safety
and health, Packaging and containers,
Penalties, Radiation protection,
Radiography, Reporting and
recordkeeping requirements, Scientific
equipment, Security measures, X-rays.
10 CFR Part 36
Byproduct material, Criminal
penalties, Nuclear energy, Nuclear
materials, Radiation protection,
Reporting and recordkeeping
requirements, Scientific equipment,
Security measures.
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................................................................................
................................................................................
................................................................................
................................................................................
monitoring ..............................................................
Amend ......................
XV. Voluntary Consensus Statement
The National Technology Transfer
and Advancement Act of 1995, Public
Law 104–113, requires that Federal
agencies use technical standards that are
developed or adopted by voluntary
consensus standards bodies unless the
use of such a standard is inconsistent
with applicable law or otherwise
impractical. In this direct final rule, the
NRC will revise parts 34, 36, and 39 by
removing the requirement to use a
personnel dosimeter that is processed
and evaluated by an accredited NVLAP
processer. This action does not
constitute the establishment of a
standard that contains generally
applicable requirements.
18:10 Mar 17, 2020
Jkt 250001
as amended; the Nuclear Waste Policy
Act of 1982, as amended; and 5 U.S.C.
552 and 553, the NRC is adopting the
following amendments to 10 CFR parts
34, 36, and 39:
PART 34—LICENSES FOR
INDUSTRIAL RADIOGRAPHY AND
RADIATION SAFETY REQUIREMENTS
FOR INDUSTRIAL RADIOGRAPHIC
OPERATIONS
1. The authority citation for part 34
continues to read as follows:
■
Authority: Atomic Energy Act of 1954,
secs. 81, 161, 181, 182, 183, 223, 234, 274 (42
U.S.C. 2111, 2201, 2231, 2232, 2233, 2273,
2282, 2021); Energy Reorganization Act of
1974, secs. 201, 206 (42 U.S.C. 5841, 5846);
44 U.S.C. 3504 note.
2. In § 34.47:
a. In paragraph (a) introductory text,
remove the phrase ‘‘that is processed
and evaluated by an accredited National
Voluntary Laboratory Accreditation
Program (NVLAP) processor’’;
■ b. Revise paragraph (a)(3);
■ c. Remove paragraph (a)(4); and
■ d. Revise paragraphs (d) and (f).
The revisions read as follows:
■
■
§ 34.47
10 CFR Part 39
Byproduct material, Criminal
penalties, Labeling, Nuclear energy,
Nuclear material, Occupational safety
and health, Oil and gas exploration—
well logging, Penalties, Radiation
protection, Reporting and recordkeeping
requirements, Scientific equipment,
Security measures, Source material,
Special nuclear material.
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,
VerDate Sep<11>2014
Personnel monitoring
Personnel monitoring
Personnel monitoring
Personnel monitoring
Records of personnel
New
Personnel monitoring.
(a) * * *
(3) Film badges must be replaced at
least monthly and all other personnel
dosimeters that require replacement
must be replaced at least quarterly. All
personnel dosimeters must be evaluated
at least quarterly or promptly after
replacement, whichever is more
frequent.
*
*
*
*
*
(d) If an individual’s pocket chamber
is found to be off-scale, or if his or her
electronic personal dosimeter reads
greater than 2 millisieverts (200
millirems), and the possibility of
radiation exposure cannot be ruled out
as the cause, the individual’s personnel
dosimeter that requires processing must
be sent for processing and evaluation
within 24 hours. For personnel
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
dosimeters that do not require
processing, evaluation of the dosimeter
must be started within 24 hours. In
addition, the individual may not resume
work associated with licensed material
use until a determination of the
individual’s radiation dose has been
made. This determination must be made
by the RSO or the RSO’s designee. The
results of this determination must be
included in the records maintained in
accordance with § 34.83.
*
*
*
*
*
(f) Dosimetry results must be retained
in accordance with § 34.83.
*
*
*
*
*
§ 34.83
[Amended]
3. In § 34.83(c), remove the phrase
‘‘received from the accredited NVLAP
processor’’.
■
PART 36—LICENSES AND RADIATION
SAFETY REQUIREMENTS FOR
IRRADIATORS
4. The authority citation for part 36
continues to read as follows:
■
Authority: Atomic Energy Act of 1954,
secs. 81, 161, 181, 182, 183, 223, 234, 274 (42
U.S.C. 2111, 2112, 2201, 2231, 2233, 2273,
2282, 2021); Energy Reorganization Act of
1974, secs. 201, 206 (42 U.S.C. 5841, 5846);
44 U.S.C. 3504 note.
5. In § 36.55, revise paragraph (a) to
read as follows:
■
§ 36.55
Personnel monitoring.
(a) Irradiator operators shall wear a
personnel dosimeter while operating a
panoramic irradiator or while in the
area around the pool of an underwater
irradiator. The personnel dosimeter
must be capable of detecting high
energy photons in the normal and
accident dose ranges. Each personnel
dosimeter must be assigned to and worn
by only one individual. Film badges
must be replaced at least monthly and
all other personnel dosimeters that
require replacement must be replaced at
least quarterly. All personnel dosimeters
E:\FR\FM\18MRR1.SGM
18MRR1
15352
Federal Register / Vol. 85, No. 53 / Wednesday, March 18, 2020 / Rules and Regulations
must be evaluated at least quarterly or
promptly after replacement, whichever
is more frequent.
*
*
*
*
*
PART 39—LICENSES AND RADIATION
SAFETY REQUIREMENTS FOR WELL
LOGGING
6. The authority citation for part 39
continues to read as follows:
■
Authority: Atomic Energy Act of 1954,
secs. 53, 57, 62, 63, 65, 69, 81, 161, 181, 182,
183, 223, 234 (42 U.S.C. 2073, 2077, 2092,
2093, 2095, 2099, 2111, 2112, 2201, 2232,
2233, 2273, 2282); Energy Reorganization Act
of 1974, secs. 201, 206 (42 U.S.C. 5841,
5846); 44 U.S.C. 3504 note.
7. In § 39.65, revise paragraph (a) to
read as follows:
■
§ 39.65
Personnel monitoring.
(a) The licensee may not permit an
individual to act as a logging supervisor
or logging assistant unless that person
wears a personnel dosimeter at all times
during the handling of licensed
radioactive materials. Each personnel
dosimeter must be assigned to and worn
by only one individual. Film badges
must be replaced at least monthly and
all other personnel dosimeters that
require replacement must be replaced at
least quarterly. All personnel dosimeters
must be evaluated at least quarterly or
promptly after replacement, whichever
is more frequent.
*
*
*
*
*
Dated at Rockville, Maryland, this 3rd day
of March, 2020.
For the Nuclear Regulatory Commission.
Margaret M. Doane,
Executive Director for Operations.
[FR Doc. 2020–05295 Filed 3–17–20; 8:45 am]
BILLING CODE 7590–01–P
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
14 CFR Part 1241
[Document Number NASA–20–028: Docket
Number—NASA–2020–0001]
RIN 2700–AE51
To Research, Evaluate, Assess, and
Treat (TREAT) Astronauts
National Aeronautics and
Space Administration (NASA).
ACTION: Interim final rule; request for
comments.
jbell on DSKJLSW7X2PROD with RULES
AGENCY:
With this interim final rule,
the National Aeronautics and Space
Administration (NASA) is amending its
regulations to add a new part that will
implement the provisions of the TREAT
SUMMARY:
VerDate Sep<11>2014
18:10 Mar 17, 2020
Jkt 250001
Astronauts Act. The new regulations
will provide for the medical monitoring
and diagnosis of conditions that are
potentially spaceflight-associated and
treatment of conditions that are
spaceflight-associated for former U.S.
Government astronauts and payload
specialists.
DATES:
Effective: March 18, 2020.
Comments due: Send comments on or
before May 18, 2020.
ADDRESSES: You may send comments,
identified by docket number NASA–
2019–0004 and/or RIN number 2700–
AE51, by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for sending comments.
• Email: HQ-TREATAstronautsAct@
nasa.gov. Include docket number
NASA–2019–0004 and/or RIN number
2700–AE51 in the subject line of the
message.
• Mail: NASA Headquarters, Mail
Code 2M21, ATTN: Gwyn E. Smith, 300
E St. SW, Washington, DC 20546–0001.
Instructions: All submissions received
must include the agency name and
docket number or Regulatory
Information Number (RIN) for this
rulemaking. All comments received will
be posted without change to https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Gwyn E. Smith, Policy Manager, Office
of the Chief Health and Medical Officer,
1–833–996–1685, HQTREATAstronautsAct@nasa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
NASA currently has a voluntary
medical monitoring program, Lifetime
Surveillance of Astronaut Health
(LSAH) program, for all U.S.
Government astronauts and payload
specialists at the NASA Johnson Space
Center (JSC). Once they leave the
astronaut corps, former U.S.
Government astronauts and payload
specialists rely on workers’
compensation and other U.S.
Government programs to provide
diagnosis and treatment for spaceflightassociated conditions. There is no
formal mechanism for NASA to receive
diagnosis and treatment data on such
conditions.
As of November 2019, there are
approximately 250 living former U.S.
Government astronauts and payload
specialists. The Agency currently
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
affords occupationally related medical
monitoring services through the LSAH
program to former U.S. Government
astronauts and payload specialists at the
JSC with a 60–70 percent participation
rate.
On March 21, 2017, the President
signed into law the National
Aeronautics and Space Administration
Transition Authorization Act of 2017,
Public Law 115–10 (2017). Title IV,
Subtitle D, the ‘‘To Research, Evaluate,
Assess, and Treat Astronauts Act’’
(hereafter ‘‘TREAT Astronauts Act’’ or
‘‘Act’’) is codified at Section 20149 of
Title 51 of the U.S. Code.
The TREAT Astronauts Act provides
NASA the authority to expand the
voluntary monitoring program by
developing a more comprehensive
occupational surveillance program that
will enable earlier detection and
diagnosis of medical conditions
‘‘potentially associated’’ with
spaceflight and treatment of medical
conditions associated with spaceflight.
NASA currently uses data from the
LSAH program to tailor clinical care for
individual astronauts, as well as to
inform the human systems risks, current
spaceflight operations, and future
vehicle standards. The comprehensive
occupational surveillance program will
provide NASA with more
comprehensive data that will ultimately
contribute to an improved
understanding of the long-term impact
of spaceflight. This enhanced program is
expected to increase the former U.S.
Government astronaut and payload
specialist participation rate in the
occupational surveillance program to
over 80 percent.
Human spaceflight poses significant
challenges and is full of substantial risk.
NASA and its astronauts acknowledge
and accept the risks of spaceflight are
beyond those of ordinary daily living.
Participation in long duration missions
or multiple shorter duration missions,
increases health risks such as, vision
impairment, bone demineralization, and
behavioral health issues. In addition,
exposure to high levels of radiation and
microgravity can result in acute and
long-term health consequences that can
increase the risk of cancer and tissue
degeneration and have potential effects
on the musculoskeletal system, central
nervous system, cardiovascular system,
immune function, and vision.
NASA has also seen an increase in
health issues former U.S. Government
astronauts and payload specialists face,
many years after their NASA service.
One of the vital tools NASA needs to
prepare for future long-duration and
exploration missions is more data on the
health effects humans face in
E:\FR\FM\18MRR1.SGM
18MRR1
]]>Agencies
[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Rules and Regulations]
[Pages 15347-15352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05295]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 85, No. 53 / Wednesday, March 18, 2020 /
Rules and Regulations
[[Page 15347]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 34, 36, and 39
[NRC-2019-0031]
RIN 3150-AK29
Individual Monitoring Devices
AGENCY: Nuclear Regulatory Commission.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
regulations to authorize the use of modern individual monitoring
devices in industrial radiographic, irradiator, and well logging
operations. These amendments will align personnel dosimetry
requirements in these areas with the requirements for all other NRC
licensees. This direct final rule addresses an issue raised in a
petition for rulemaking and will affect NRC and Agreement State
licensees. The NRC also is issuing supplemental guidance for use and
comment with this direct final rule.
DATES: This direct final rule and supplemental guidance are effective
June 16, 2020. If adverse comments on the direct final rule are
received by April 17, 2020 the direct final rule will be withdrawn. If
the direct final rule is withdrawn, the supplemental guidance also is
withdrawn; timely notice of the withdrawal will be published in the
Federal Register. Comments received after this date will be considered
if it is practical to do so, but the NRC is able to ensure
consideration only for comments received on or before this date. If the
direct final rule is withdrawn, comments will be addressed in a
subsequent final rule. Comments received on this direct final rule and
supplemental guidance will also be considered as comments on the
companion proposed rule published in the Proposed Rules section of this
issue of the Federal Register.
ADDRESSES: You may submit comments by any of the following methods:
Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0031. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions contact
the individuals listed in the FOR FURTHER INFORMATION CONTACT section
of this document.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Anthony McMurtray, telephone: 301-415-
2746; email: [email protected]; or Edward Lohr, telephone: 301-
415-0253; email: [email protected]. Both are staff of the Office of
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Obtaining Information and Submitting Comments
II. Rulemaking Procedure
III. Background
IV. Discussion
V. Guidance Documents
VI. Section-by-Section Analysis
VII. Regulatory Analysis
VIII. Regulatory Flexibility Certification
IX. Backfitting and Issue Finality
X. Plain Writing
XI. National Environmental Policy Act
XII. Paperwork Reduction Act Statement
XIII. Congressional Review Act
XIV. Compatibility of Agreement State Regulations
XV. Voluntary Consensus Standards
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2019-0031 when contacting the NRC
about the availability of information for this action. You may obtain
publicly-available information related to this action by any of the
following methods:
Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0031.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or
by email to [email protected]. The ADAMS accession number for each
document referenced (if it is available in ADAMS) is provided the first
time that it is mentioned in this document.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2019-0031 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at
https://www.regulations.gov as well as enter the comment submissions
into ADAMS. The NRC does not routinely edit comment submissions to
remove identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
[[Page 15348]]
II. Rulemaking Procedure
Because the NRC considers this action to be non-controversial, the
NRC is using the direct final rule procedure for this rule. The
amendment to the rule will become effective on June 16, 2020. However,
if the NRC receives significant adverse comments on this direct final
rule by April 17, 2020, then the NRC will publish a document that
withdraws this direct final rule, as well as the associated
supplemental guidance. In such a case, the NRC will treat comments on
this direct final rule as comments on the companion proposed rule
published in the Proposed Rules section of this issue of the Federal
Register. Absent significant modifications to the proposed revisions
requiring republication, the NRC will not initiate a second comment
period on this action.
A significant adverse comment is a comment where the commenter
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without a change. A comment is adverse and significant if:
(1) The comment opposes the rule and provides a reason sufficient
to require a substantive response in a notice-and-comment process. For
example, a substantive response is required when:
(a) The comment causes the NRC to reevaluate (or reconsider) its
position or conduct additional analysis;
(b) The comment raises an issue serious enough to warrant a
substantive response to clarify or complete the record; or
(c) The comment raises a relevant issue that was not previously
addressed or considered by the NRC.
(2) The comment proposes a change or an addition to the rule, and
it is apparent that the rule would be ineffective or unacceptable
without incorporation of the change or addition.
(3) The comment causes the NRC to make a change (other than
editorial) to the rule.
For detailed instructions on filing comments, please see the
ADDRESSES section of this document.
III. Background
The regulations in part 34 of title 10 of the Code of Federal
Regulations (10 CFR), ``Licenses for Industrial Radiography and
Radiation Safety Requirements for Industrial Radiographic Operations'';
10 CFR part 36, ``Licenses and Radiation Safety Requirements for
Irradiators''; and 10 CFR part 39, ``Licenses and Radiation Safety
Requirements for Well Logging,'' require the use of personnel dosimetry
that is processed and evaluated by an accredited National Voluntary
Laboratory Accreditation Program (NVLAP) processor. These regulations
restrict the types of personnel dosimeters that can be used and
prohibit the use of dosimetry technologies that do not require
processing by an accredited NVLAP facility.
On July 14, 2016, the NRC received a petition for rulemaking (PRM)
from the American Society for Nondestructive Testing and the
Nondestructive Testing Management Association (the petitioners) (ADAMS
Accession No. ML16228A045). The petition was docketed by the NRC on
August 12, 2016, and assigned Docket No. PRM-34-7. The NRC published a
notice of docketing of PRM-34-7 in the Federal Register (81 FR 78732)
on November 9, 2016. The petitioners requested that the NRC amend its
regulations and associated guidance to authorize the use of improved
individual monitoring devices for industrial radiographic personnel.
Specifically, the petitioners requested that the NRC amend its
regulations to authorize the use of digital output personnel dosimeters
to satisfy the personnel dosimetry requirements in Sec. 34.47(a).
Personnel dosimetry is a specific type of dosimetry that is used to
track an individual worker's dose. The petitioners interchangeably used
the terms ``improved individual monitoring devices,'' ``electronic
personnel monitoring dosimeters,'' ``electronic dosimeters,'' and
``digital personnel dosimeters'' to describe digital output personnel
dosimetry. In this direct final rule, the NRC uses the term ``digital
output personnel dosimetry'' in place of these terms. A digital output
personnel dosimeter is a specific type of personnel dosimetry that
currently cannot be used to meet the requirements in 10 CFR parts 34,
36, and 39 to demonstrate compliance with the occupational dose limits
in Sec. 20.1201.
On February 11, 2019, the NRC published a document in the Federal
Register (84 FR 3116) informing the public that it would consider PRM-
34-7 in the rulemaking process. In the Federal Register document, the
NRC accepted the petitioners' request that the NRC amend its
regulations to authorize the use of digital output personnel dosimeters
for industrial radiographic personnel and expanded the scope of the
rulemaking to include the use of digital output personnel dosimeters in
irradiator and well logging operations.
IV. Discussion
The NRC's requirements related to the safe use of sealed sources of
byproduct material in industrial radiography are codified in 10 CFR
part 34. The regulation in Sec. 34.47(a) states that during
radiographic operations, radiographers and radiographer's assistants
must wear ``a direct reading dosimeter, an operating alarm ratemeter,
and a personnel dosimeter that is processed and evaluated by an
accredited National Voluntary Laboratory Accreditation Program (NVLAP)
processor.''
Although ``processing'' is not defined in the regulations, the NRC
uses it with a specific meaning related to personnel dosimetry. The NRC
interprets processing to mean a process, separate from and independent
of the design of the dosimeter, that is required to extract dose
information from the dosimeter after exposure to radiation. Processing
is necessary with film, thermoluminescent dosimetry (TLD), and
optically stimulated luminescence (OSL) dosimetry to obtain the dose
information. With film, TLD, and OSL dosimetry, the quality of the
processing is dependent on the competence of the processor and not on
the dosimeter design, whereas quality is built into the design of
dosimeters that do not require processing. An in-depth discussion on
this topic can be found in the January 14, 2005, Federal Register
document (70 FR 2577) denying a petition for rulemaking (PRM-20-25).
Film, TLD, and OSL dosimeters are examples of devices that require
processing by qualified technicians using separate equipment to obtain
data that is used to compute the dose measurement. Therefore, these
types of dosimeters must be processed by an accredited NVLAP facility
to ensure the quality of the processing. The NVLAP does not certify or
accredit dosimetry devices themselves; it only certifies or accredits
device processing. Accreditation by the NVLAP provides a level of
assurance of quality of the measurement (i.e., accuracy, precision, and
reliability) for processors.
Some recently designed personnel dosimeters do not require the type
of processing envisioned in the text of Sec. 34.47(a)--that is, data
extraction through a process independent of the dosimeter. For example,
some personnel dosimeters can provide instantaneous dose readings using
internet-enabled computers, smartphones, and tablets. Data is extracted
from the detector and then digitally transferred from the dosimeter for
computation. The design of the personnel dosimeter, rather than
[[Page 15349]]
the training and qualifications of the processing technician, ensures
accurate dose information from the dosimeter after exposure to
radiation.
Current regulations in Sec. 34.47(a) and similar provisions in 10
CFR parts 36 and 39 require use of personnel dosimeters that require
processing. This direct final rule eliminates these requirements for
personnel dosimeters that require processing. The requirements in 10
CFR part 20 will continue to provide standards for the use of all
personnel dosimeters.
The NRC considered recent peer-reviewed literature and NRC
documents on the performance of digital output personnel dosimeters
that were authorized by Agreement State and NRC licensees. The NRC
determined that digital output personnel dosimetry has been used
successfully by NRC licensees in other operational settings, by some
Agreement State licensees in all areas--including industrial
radiography, and internationally in multiple applications. The NRC did
not find any evidence of generic performance problems with digital
output personnel dosimetry in other operating settings, nor did the NRC
identify any adverse trends that would preclude the use of this
dosimetry by all NRC licensees.
In addition, the NRC evaluated the technical specifications of
currently available digital output personnel dosimetry and determined
that they met or exceeded performance standards, operability criteria
(e.g., temperature, humidity), dose ranges, and quality control
expectations for use in industrial radiographic, irradiator, and well
logging operations. The NRC did not identify issues that would preclude
the use of digital output personnel dosimetry in industrial
radiographic, irradiator, or well logging operations.
Therefore, the NRC determined that there is no technical basis for
continuing to limit the types of personnel dosimeters used in
industrial radiography, irradiator, and well logging operations to only
those that are processed and evaluated by an accredited NVLAP
processor. The levels and types of radiation fields encountered in
these operations are also encountered in other industries where digital
output personnel dosimeters already are allowed. The NRC determined
that mandating the use of a particular type of personnel dosimetry will
not prevent or reduce the dose received or result in more accurate,
precise, or reliable measurements.
In addition, having access to digital output personnel dosimeters
is especially beneficial to industrial radiography licensees. Under
Sec. 34.47(d), certain circumstances require workers to cease work
immediately until their radiation dose has been determined. This can
involve three or more days of wait time while the personnel dosimeter
is sent off-site for processing and evaluation, which could cost the
licensee revenue and lost time. Workers using digital output personnel
dosimeters do not need to send their dosimeters to a processor and can
have their radiation dose determined locally so that the issue can be
resolved quickly.
Consistent with the agency's focus on implementing risk-informed,
performance-based regulations and transforming its regulatory
approaches, the NRC is amending the requirements for licensees under 10
CFR parts 34, 36, and 39 to enable the use of any personnel dosimeters.
Removing the requirement to use personnel dosimeters that are processed
and evaluated by an accredited NVLAP facility will allow the use of
digital output personnel dosimeters (which do not require processing)
and ensure all NRC licensees are held to the same standards for
personnel dosimetry. Also, because the current regulations are based on
the use of film, TLD, and OSL dosimeters (all of which require
processing by an accredited NVLAP processor), conforming and clarifying
changes related to exchange intervals, monitoring, and recordkeeping
are being made to 10 CFR parts 34, 36, and 39 to address personnel
dosimeters that do not require processing. These amendments will allow
greater consistency with the Agreement States' programs.
On May 11, 2018, the NRC issued an Enforcement Guidance Memorandum
(EGM-18-001) that provides guidance for dispositioning potential
violations of NRC requirements for personnel dosimetry during NRC-
licensed activities under 10 CFR parts 34, 36, and 39 (ADAMS Accession
No. ML18068A623). In the EGM, the NRC stated that industrial
radiographic, irradiator, and well logging licensees who use digital
output personnel dosimetry for personnel monitoring (i.e., dosimetry
used for the dose of record) would not be subject to enforcement action
for some potential violations of NRC requirements associated with the
use of these dosimeters provided that specified conditions are met. The
NRC considered the specific conditions specified in EGM-18-001 during
the development of this direct final rule. The EGM will expire when
this direct final rule becomes effective.
V. Guidance Documents
The NRC is issuing supplemental guidance in conjunction with this
direct final rule. Guidance on 10 CFR parts 34, 36, and 39 is provided
in NUREG-1556, ``Consolidated Guidance About Materials Licenses,'' in
the volumes for industrial radiography (Volume 2), irradiators (Volume
6), and well logging (Volume 14). This supplemental guidance is
intended for use by applicants, licensees, Agreement States, and the
NRC staff when personnel dosimeters that do not require processing are
being used. It includes guidance to applicants for the completion and
submission of materials license applications to the NRC and model
procedures that an applicant or licensee may consider when developing
or changing its radiation safety program.
The supplemental guidance documents (ADAMS package Accession No.
ML19360A184) are in a markup format to NRC's existing guidance and
reflect the provisions in the direct final rule. On the effective date
of the direct final rule, licensees that elect to use personnel
dosimeters that do not require processing may use the supplemental
guidance to comply with the provisions in the direct final rule.
Comments on the supplemental guidance may be submitted as directed
in Section I, ``Obtaining Information and Submitting Comments,'' of
this document. The NRC will incorporate this supplemental guidance into
the next comprehensive revision of NUREG-1556.
VI. Section-by-Section Analysis
The following paragraphs describe the specific changes made in this
direct final rule.
Section 34.47 Personnel Monitoring
In Sec. 34.47, this direct final rule revises paragraph (a) by
removing the requirement to use a personnel dosimeter that is processed
and evaluated by an accredited NVLAP processer, revises paragraph
(a)(3) to make conforming changes, and removes paragraph (a)(4).
Paragraph (d) is revised to include the requirement to begin
evaluating an individual's personnel dosimeter within 24 hours for
personnel dosimeters that do not require processing, if the conditions
in the paragraph are met.
Paragraph (f) is revised to state that all dosimetry results
received by a licensee are to be retained in accordance with Sec.
34.83.
[[Page 15350]]
Section 34.83 Records of Personnel Monitoring Procedures
In Sec. 34.83, this direct final rule revises paragraph (c) by
removing the phrase ``received from the accredited NVLAP processor.''
Section 36.55 Personnel Monitoring
In Sec. 36.55, this direct final rule revises paragraph (a) by
removing the requirement to use a personnel dosimeter that is processed
and evaluated by an accredited NVLAP processer and clarifying that all
personnel dosimeters must be capable of detecting high energy photons
in the normal and accident dose ranges. The reference to Sec.
20.1501(c) is removed because it does not apply to all personnel
dosimetry. Conforming changes are made to clarify that personnel
dosimeters that require processing must be replaced at appropriate
intervals, that all personnel dosimeters must be evaluated promptly
after replacement and at least quarterly, and an individual's radiation
dose must be determined at periods not to exceed three months.
Section 39.65 Personnel Monitoring
In Sec. 39.65, this direct final rule revises paragraph (a) by
removing the requirement to use a personnel dosimeter that is processed
and evaluated by an accredited NVLAP processer. Conforming changes are
made to clarify that personnel dosimeters that require processing must
be replaced at appropriate intervals, that all personnel dosimeters
must be evaluated promptly after replacement and at least quarterly,
and an individual's radiation dose must be determined at periods not to
exceed three months.
VII. Regulatory Analysis
The NRC has prepared a regulatory analysis (ADAMS Accession No.
ML19283B555) to support this direct final rule. The analysis examines
the costs and benefits of the alternatives considered by the NRC.
VIII. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC
certifies that this direct final rule will not, if issued, have a
significant economic impact on a substantial number of small entities.
This direct final rule affects a number of ``small entities'' as
defined by the Regulatory Flexibility Act or the size standards
established by the NRC (Sec. 2.810). However, as indicated in the
regulatory analysis, these amendments do not have a significant
economic impact on the affected small entities.
IX. Backfitting and Issue Finality
The revisions to 10 CFR parts 34, 36, and 39 would not constitute
backfitting as these parts do not have a backfitting provision. In
addition, the revisions would not impose any additional requirements.
Personnel dosimeters that are not processed would be authorized for
voluntary use by licensees, but not required.
X. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has written this document to be consistent with the
Plain Writing Act as well as the Presidential Memorandum, ``Plain
Language in Government Writing,'' published June 10, 1998 (63 FR
31885).
XI. National Environmental Policy Act
The NRC has determined that this direct final rule is the type of
action described in Sec. 51.22(c)(2). Therefore, neither an
environmental impact statement nor environmental assessment has been
prepared for this direct final rule.
XII. Paperwork Reduction Act
This direct final rule does not contain any new or amended
collections of information subject to the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.). Existing collections of information were
approved by the Office of Management and Budget, approval numbers 3150-
0007, 3150-0130, and 3150-0158.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless the document requesting
or requiring the collection displays a currently valid OMB control
number.
XIII. Congressional Review Act
This direct final rule is a rule as defined in the Congressional
Review Act (5 U.S.C. 801-808). However, the Office of Management and
Budget has not found it to be a major rule as defined in the
Congressional Review Act.
XIV. Compatibility of Agreement State Regulations
Under the ``Agreement State Program Policy Statement'' approved by
the Commission on October 2, 2017 and published in the Federal Register
on October 18, 2017 (82 FR 48535), the NRC program elements (including
regulations) are placed into Compatibility Categories A, B, C, D, NRC,
or Adequacy Category Health and Safety (H&S). Compatibility Category A
are those program elements that are basic radiation protection
standards and scientific terms and definitions that are necessary to
understand radiation protection concepts. An Agreement State should
adopt Category A program elements in an essentially identical manner in
order to provide uniformity in the regulation of agreement material on
a nationwide basis. Compatibility Category B are those program elements
that apply to activities that have direct and significant effects in
multiple jurisdictions. An Agreement State should adopt Category B
program elements in an essentially identical manner. Compatibility
Category C are those program elements that do not meet the criteria of
Category A or B, but the essential objectives of which an Agreement
State should adopt to avoid conflict, duplication, gaps, or other
conditions that would jeopardize an orderly pattern in the regulation
of agreement material on a national basis. An Agreement State should
adopt the essential objectives of the Category C program elements.
Compatibility Category D are those program elements that do not meet
any of the criteria of Category A, B, or C, and thus, do not need to be
adopted by Agreement States for purposes of compatibility.
Compatibility Category NRC are those program elements that address
areas of regulation that cannot be relinquished to the Agreement States
under the Atomic Energy Act of 1954, as amended, or provisions of title
10 of the Code of Federal Regulations. These program elements should
not be adopted by the Agreement States. Compatibility Category H&S are
program elements that are required because of a particular health and
safety role in the regulation of agreement material within the State
and should be adopted in a manner that embodies the essential
objectives of the NRC program.
This direct final rule is a matter of compatibility between the NRC
and the Agreement States, thereby providing consistency among Agreement
State and the NRC requirements. The compatibility categories are
designated in the following table:
[[Page 15351]]
Compatibility Table
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject ---------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
Part 34:
34.47(a)........................ Amend.............. Personnel monitoring... C.............. C
34.47(a)(3)..................... Amend.............. Personnel monitoring... C.............. C
34.47(d)........................ Amend.............. Personnel monitoring... C.............. C
34.47(f)........................ Amend.............. Personnel monitoring... C.............. C
34.83(c)........................ Amend.............. Records of personnel C.............. C
monitoring.
Part 36:
36.55(a)........................ Amend.............. Personnel monitoring... H&S............ H&S
Part 39:
39.65(a)........................ Amend.............. Personnel monitoring C.............. C
devices.
----------------------------------------------------------------------------------------------------------------
XV. Voluntary Consensus Statement
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that Federal agencies use technical
standards that are developed or adopted by voluntary consensus
standards bodies unless the use of such a standard is inconsistent with
applicable law or otherwise impractical. In this direct final rule, the
NRC will revise parts 34, 36, and 39 by removing the requirement to use
a personnel dosimeter that is processed and evaluated by an accredited
NVLAP processer. This action does not constitute the establishment of a
standard that contains generally applicable requirements.
List of Subjects
10 CFR Part 34
Criminal penalties, Manpower training programs, Occupational safety
and health, Packaging and containers, Penalties, Radiation protection,
Radiography, Reporting and recordkeeping requirements, Scientific
equipment, Security measures, X-rays.
10 CFR Part 36
Byproduct material, Criminal penalties, Nuclear energy, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements, Scientific equipment, Security measures.
10 CFR Part 39
Byproduct material, Criminal penalties, Labeling, Nuclear energy,
Nuclear material, Occupational safety and health, Oil and gas
exploration--well logging, Penalties, Radiation protection, Reporting
and recordkeeping requirements, Scientific equipment, Security
measures, Source material, Special nuclear material.
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; the Nuclear Waste Policy Act of 1982, as
amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following
amendments to 10 CFR parts 34, 36, and 39:
PART 34--LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY
REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
0
1. The authority citation for part 34 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182,
183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273,
2282, 2021); Energy Reorganization Act of 1974, secs. 201, 206 (42
U.S.C. 5841, 5846); 44 U.S.C. 3504 note.
0
2. In Sec. 34.47:
0
a. In paragraph (a) introductory text, remove the phrase ``that is
processed and evaluated by an accredited National Voluntary Laboratory
Accreditation Program (NVLAP) processor'';
0
b. Revise paragraph (a)(3);
0
c. Remove paragraph (a)(4); and
0
d. Revise paragraphs (d) and (f).
The revisions read as follows:
Sec. 34.47 Personnel monitoring.
(a) * * *
(3) Film badges must be replaced at least monthly and all other
personnel dosimeters that require replacement must be replaced at least
quarterly. All personnel dosimeters must be evaluated at least
quarterly or promptly after replacement, whichever is more frequent.
* * * * *
(d) If an individual's pocket chamber is found to be off-scale, or
if his or her electronic personal dosimeter reads greater than 2
millisieverts (200 millirems), and the possibility of radiation
exposure cannot be ruled out as the cause, the individual's personnel
dosimeter that requires processing must be sent for processing and
evaluation within 24 hours. For personnel dosimeters that do not
require processing, evaluation of the dosimeter must be started within
24 hours. In addition, the individual may not resume work associated
with licensed material use until a determination of the individual's
radiation dose has been made. This determination must be made by the
RSO or the RSO's designee. The results of this determination must be
included in the records maintained in accordance with Sec. 34.83.
* * * * *
(f) Dosimetry results must be retained in accordance with Sec.
34.83.
* * * * *
Sec. 34.83 [Amended]
0
3. In Sec. 34.83(c), remove the phrase ``received from the accredited
NVLAP processor''.
PART 36--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
0
4. The authority citation for part 36 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182,
183, 223, 234, 274 (42 U.S.C. 2111, 2112, 2201, 2231, 2233, 2273,
2282, 2021); Energy Reorganization Act of 1974, secs. 201, 206 (42
U.S.C. 5841, 5846); 44 U.S.C. 3504 note.
0
5. In Sec. 36.55, revise paragraph (a) to read as follows:
Sec. 36.55 Personnel monitoring.
(a) Irradiator operators shall wear a personnel dosimeter while
operating a panoramic irradiator or while in the area around the pool
of an underwater irradiator. The personnel dosimeter must be capable of
detecting high energy photons in the normal and accident dose ranges.
Each personnel dosimeter must be assigned to and worn by only one
individual. Film badges must be replaced at least monthly and all other
personnel dosimeters that require replacement must be replaced at least
quarterly. All personnel dosimeters
[[Page 15352]]
must be evaluated at least quarterly or promptly after replacement,
whichever is more frequent.
* * * * *
PART 39--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL
LOGGING
0
6. The authority citation for part 39 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 65,
69, 81, 161, 181, 182, 183, 223, 234 (42 U.S.C. 2073, 2077, 2092,
2093, 2095, 2099, 2111, 2112, 2201, 2232, 2233, 2273, 2282); Energy
Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846);
44 U.S.C. 3504 note.
0
7. In Sec. 39.65, revise paragraph (a) to read as follows:
Sec. 39.65 Personnel monitoring.
(a) The licensee may not permit an individual to act as a logging
supervisor or logging assistant unless that person wears a personnel
dosimeter at all times during the handling of licensed radioactive
materials. Each personnel dosimeter must be assigned to and worn by
only one individual. Film badges must be replaced at least monthly and
all other personnel dosimeters that require replacement must be
replaced at least quarterly. All personnel dosimeters must be evaluated
at least quarterly or promptly after replacement, whichever is more
frequent.
* * * * *
Dated at Rockville, Maryland, this 3rd day of March, 2020.
For the Nuclear Regulatory Commission.
Margaret M. Doane,
Executive Director for Operations.
[FR Doc. 2020-05295 Filed 3-17-20; 8:45 am]
BILLING CODE 7590-01-P
