[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Proposed Rules]
[Pages 3116-3120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01792]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 34, 36, and 39

[Docket No. PRM-34-7; NRC-2016-0182]


Individual Monitoring Devices for Industrial Radiographic 
Personnel

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; partial consideration in the 
rulemaking process.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will consider in 
its rulemaking process one issue raised in a petition for rulemaking 
(PRM), PRM-34-7, submitted by the American Society for Nondestructive 
Testing (ASNT) and the Nondestructive Testing

[[Page 3117]]

Management Association (NDTMA), and is denying one aspect of PRM-34-7. 
The petitioners request that the NRC amend its regulations to authorize 
the use of ``improved'' individual monitoring devices for industrial 
radiographic personnel.

DATES: The docket for the petition for rulemaking, PRM-34-7, is closed 
on February 11, 2019.

ADDRESSES: Please refer to Docket ID NRC-2016-0182 when contacting the 
NRC about the availability of information for this petition. You may 
obtain publicly-available information related to this action by any of 
the following methods:
     Federal Rulemaking website: Public comments and supporting 
materials related to this petition can be found at http://www.regulations.gov by searching on the petition Docket ID NRC-2016-
0182 or the future rulemaking 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 individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     The NRC's Agencywide Documents Access and Management 
System (ADAMS): You may obtain publicly-available documents online in 
the ADAMS Public Document collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then 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 the 
SUPPLEMENTARY INFORMATION section.
     The NRC's PDR: You may examine and purchase copies of 
public documents at the NRC's PDR, O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone: 301-415-0253; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. The Petition

    The NRC received and docketed a petition for rulemaking (ADAMS 
Accession No. ML16228A045) dated July 14, 2016, filed by Dr. Arny 
Bereson of ASNT and Mr. Walt Cofer of NDTMA.\1\ On November 9, 2016 (81 
FR 78732), the NRC published a notice of docketing and requested public 
comment on the petition.
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    \1\ The November 2016 Federal Register notice incorrectly 
identified each petitioner's organization.
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    The NRC identified two issues in the petition, as follows:
    Issue 1: The petitioners request that the NRC amend its regulations 
to authorize the use of digital output personnel dosimeters to satisfy 
the requirements in Sec.  34.47(a) in title 10 of the Code of Federal 
Regulations (10 CFR).
    Issue 2: The petitioners request that the NRC amend its regulations 
to authorize the use of dual-function electronic alarming dosimeters 
(EADs) to satisfy the requirements in Sec.  34.47(a).
    The petitioners interchangeably use the terms ``improved individual 
monitoring devices,'' ``electronic personnel monitoring dosimeters,'' 
``electronic dosimeters,'' and ``digital personnel dosimeters'' to 
describe ``improved'' personnel dosimetry. This document uses the term 
``digital output personnel dosimetry'' in place of these terms, and 
clarifies that digital output personnel dosimety is a specific type of 
personnel dosimetry used to demonstrate compliance with the 
occupational dose limits in Sec.  20.1201. The petitioners use the 
terms ``dual-function alarm ratemeter/electronic dosimeter'' and 
``dual-function electronic dosimeter/alarm ratemeter'' to describe 
devices that combine the functions of the alarm ratemeter and direct 
reading dosimeter required under Sec.  34.47(a). This document uses the 
term ``EADs'' to describe these dual-function devices.

II. Public Comments on the Petition

    The notice of docketing of PRM-34-7 invited interested persons to 
submit comments, and the comment period closed on January 23, 2017. The 
NRC received 13 comment submissions on the PRM.\2\
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    \2\ One commenter retracted his original comment and submitted a 
replacement comment.
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    In the notice of docketing, the NRC requested public comment and 
supporting rationale in three specific areas: (1) How the use of dual-
function EADs could achieve the current safety purpose of using 
independent devices; (2) whether changes similar to those proposed in 
the petition should be applied to other radiation protection regulatory 
requirements, such as those in 10 CFR part 36, ``Licenses and Radiation 
Safety Requirements for Irradiators,'' and 10 CFR part 39, ``Licenses 
and Radiation Safety Requirements for Well Logging''; and (3) what 
experiences or challenges users have encountered in the use of digital 
output personnel dosimeters. Not all commenters submitted comments on 
all three specific areas of interest. None of the commenters referenced 
publicly-available technical, scientific, or other data or information 
to support their positions.
    Public comments were received from industry, government and non-
government organizations, and members of the public. The name of the 
submitter, the submitter's affiliation (if any), and the ADAMS 
accession number for each unique comment submission are provided in the 
following table.

----------------------------------------------------------------------------------------------------------------
              Comment #                  ADAMS Accession No.           Commenter               Affiliation
----------------------------------------------------------------------------------------------------------------
1....................................  ML16326A439............  Sander Perle...........  Private Citizen.
2....................................  ML17039A670............  Cody A. Bayn...........  Private Citizen.
3....................................  ML16349A645............  Anonymous..............  Anonymous.
4....................................  ML16356A574............  Brian Companik.........  Private Citizen.
5....................................  ML16356A658............  Kyle Ledbetter.........  International
                                                                                          Radiography Inspection
                                                                                          Service Non-
                                                                                          Destructive Testing.
6....................................  ML16356A663............  Anonymous..............  Anonymous.
7....................................  ML17017A339............  Rick Ruhge.............  Private Citizen.
8....................................  ML17018A431............  Nima Askeboussi........  Nuclear Energy
                                                                                          Institute.
9....................................  ML17024A384............  Steve Matthews.........  State of Washington.
10...................................  ML17024A400............  David Tebo.............  TEAM Industrial
                                                                                          Services, Inc.
11...................................  ML17024A415............  John Merrill...........  Consumers Energy.

[[Page 3118]]

 
12...................................  ML17024A440............  Mark Salasky...........  Landauer, Inc.
13...................................  ML17024A447............  James A. Brink.........  American College of
                                                                                          Radiology.
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    The NRC binned the public comments into three groups based on the 
areas of interest highlighted in the notice. The NRC reviewed and 
considered the comments in its decision to accept or deny the issues 
raised by the petitioners. The following discussion provides a summary 
of each area of interest addressed in the public comments and the NRC's 
response to those comments.

NRC's Responses to Comments on PRM-34-7

    Area 1: Could the use of dual-function EADs achieve the current 
safety purpose of using independent devices?
    Comment: The new technology is more reliable, more accurate, and 
less likely to give false readings than the devices currently allowed 
under Sec.  34.47(a). The new technology offers more safety options for 
the worker, such as vibrating, audible, and visual alarm capabilities. 
(Commenters 1, 2, 4, 5, and 7 through 11)
    NRC Response: The NRC agrees with the comment. In a memorandum 
dated April 4, 2017 (ADAMS Accession No. ML17095A319), the NRC 
concluded that dual-function EADs were reliable and had a proven track 
record at nuclear power plants. Furthermore, on September 19, 2017, the 
NRC issued Regulatory Issue Summary (RIS) 2017-06, ``NRC Policy on Use 
of Combination Dosimetry Devices during Industrial Radiographic 
Operations'' (ADAMS Accession No. ML16137A077), clarifying that dual-
function EADs (also referred to as combination dosimetry devices in the 
RIS) may be used to satisfy the requirements in Sec.  34.47(a).
    Comment: Defense-in-depth safety that is provided by the use of 
single-function devices will be lost if dual-function EAD devices are 
allowed to be used to meet the requirements in Sec.  34.47(a). 
(Commenters 3 and 6)
    NRC Response: The NRC disagrees with the comment. Dual-function 
EADs that combine the functions of an alarm ratemeter and a direct 
reading dosimeter do not compromise defense-in-depth (backup) provided 
by the single devices. The survey meter required under Sec.  34.49(a) 
provides redundancy (backup) for the function of the operating alarm 
ratemeter. An individual's personnel dosimeter, required by Sec.  
34.47(a), provides redundancy (backup) for the function of the direct 
reading dosimeter.
    Comment: Having all the dosimetry concentrated in a single device 
will present an all-or-nothing scenario to industrial radiographers who 
forget the device. It is extremely likely that the temptation will be 
there for a company or individual to use his or her multimeter as a 
survey meter of sorts. By doing so, he or she negates the value of the 
dosimetry, which will no longer correspond to the exposures experienced 
by his or her body. In the event of an exposure event, the individual's 
dosimetry will therefore likely report a higher value than actually 
experienced. (Commenter 6)
    NRC Response: The NRC interprets this comment to mean that 
combining all the functions of the devices required by Sec.  34.47(a) 
(the alarm ratemeter, the direct reading dosimeter, and the personnel 
dosimeter) would compromise the defense-in-depth safety provided by 
three single devices. The NRC determined that the comment was out of 
scope as the petitioner's request was specifically for the use of dual-
function EADs and not for a single device that combined all the 
functions required by Sec.  34.47(a). Although this comment is beyond 
the scope of PRM-34-7, the NRC may consider this subject in a future 
rulemaking that will potentially propose performance-based standards 
for 10 CFR part 34 (``Industrial Radiographic Operations and Training'' 
rulemaking, Docket ID NRC-2017-0022).
    Comment: It is possible for a ``single advanced electronic device'' 
to fulfill both operational needs of timely dose evaluations and 
integrated dose reporting, improving dosimetry monitoring of the 
individual and management of the entire radiological program. 
(Commenter 12)
    NRC Response: Although the technology may be available now or in 
the immediate future to have a single electronic device that meets all 
the requirements in Sec.  34.47(a), current regulations do not have a 
performance standard for this type of device. Although this comment is 
beyond the scope of PRM-34-7, the NRC may consider this subject in a 
future rulemaking that will potentially propose performance-based 
standards for 10 CFR part 34 (``Industrial Radiographic Operations and 
Training'' rulemaking, Docket ID NRC-2017-0022).
    Comment: Electronic transfer of dosimeter data utilizing the 
internet and wireless communication will improve data integrity and 
compliance compared to hand recording and data transfer. Advanced 
digital electronic devices can include additional features to determine 
irradiation conditions (e.g., geometry and motion) and compliance 
(e.g., was the dosimeter worn?). These additional features should be 
considered in any evaluation concerning the modification of any 
regulations or guidelines. (Commenter 12)
    NRC Response: The NRC agrees with the comment that additional 
features built into electronic devices for use as personnel dosimeters 
may have safety and operational benefits. Although this comment is 
beyond the scope of PRM-34-7, the NRC may consider this subject in a 
future rulemaking that will potentially propose performance-based 
standards for 10 CFR part 34 (``Industrial Radiographic Operations and 
Training'' rulemaking, Docket ID NRC-2017-0022).
    Comment: How will the proposed combination device be calibrated for 
correct response to radiation? An alarming ratemeter already has 
calibration requirements under 10 CFR part 34, but what of the 
dosimetry functions? Users of film badges never had to worry about this 
because they were sent out for processing. (Commenter 6)
    NRC Response: The NRC interprets this comment to mean the commenter 
was concerned that dual-function EADs will have different calibration 
requirements than devices currently required under Sec.  34.47(a). The 
NRC disagrees with the comment. The direct reading dosimeter part of 
the dual-function EAD is still considered a ``secondary'' dosimeter; 
that is, it is not intended to be used for directly determining an 
individual's dose of record. The worker is still required to use a 
``primary'' personnel dosimeter such as a film badge, thermoluminescent 
device, optically stimulated luminescence device, or other approved 
personnel dosimeter for the dose of record. Therefore, any calibration 
procedures previously used for the direct reading dosimeters, such as 
those used for a personal ionization chamber, would continue to apply 
for the direct reading dosimeter part of the dual-function EAD.

[[Page 3119]]

    Comment: How long can a multimeter be trusted to function within 
the required ranges? (Commenter 6)
    NRC Response: The NRC interprets this comment to mean the commenter 
was concerned that dual-function EADs (multimeters) will not stay in 
calibrated ranges for the period between calibrations. The NRC 
disagrees with the comment. In a memorandum dated April 4, 2017 (ADAMS 
Accession No. ML17095A319), the NRC concluded that dual-function EADs 
were reliable and had a proven track record at nuclear power plants. 
All aspects of the use of dual-function EADs, including calibration, 
were reviewed and no issues were identified.
    Area 2: Should changes similar to those proposed in the petition be 
applied to other radiation protection regulatory requirements, such as 
those in 10 CFR parts 36 and 39?
    Comment: While the PRM focuses on 10 CFR part 34, emerging 
monitoring technologies can be adopted by other licensees that will 
also benefit from revised rule language and related guidance. 
Therefore, in principle, we support the PRM and recommend that the NRC 
revise rule language and related guidance to allow a more performance-
based approach that recognizes the use of emerging personnel monitoring 
technology to demonstrate regulatory compliance. (Commenter 8)
    NRC Response: The NRC agrees with the comment. Amending the 
requirements for personnel dosimetry at 10 CFR parts 36 and 39 would 
provide other licensees the same benefit of access to modern dosimetry 
as requested for part 34 by the petitioners. When appropriate, NRC 
develops regulations and guidance that are performance-based.
    Comment: While PRM-34-7 was submitted for NRC consideration with 
industrial radiography stakeholders in mind, the American College of 
Radiology believes the spirit of the PRM should be adopted and 
explicitly applied to medical radiation workers (i.e., via the 
pertinent subparts of 10 CFR part 20) to protect the continued use of 
advanced technology dosimeters within the medical community, including 
medical applications of radiation not directly under the NRC's 
oversight. (Commenter 13)
    NRC Response: The NRC interprets this comment to mean that the 
commenter did not want any changes made to the regulations that will 
hinder the current use of digital output personnel dosimetry by 10 CFR 
part 35 licensees. The NRC agrees with the comment. In authorizing the 
use of digital output personnel dosimeters to satisfy the requirements 
in Sec.  34.47(a) (i.e., accepting Issue 1), the NRC intends to expand 
the availability of digital output personnel dosimeters to licensees 
licensed under 10 CFR parts 34, 36, and 39 and not hinder the current 
use of the dosimetry by other licensees.
    Comment: If the NRC were to deny PRM-34-7, it will set a 
detrimental precedent for State programs that will likely sweep across 
the broader stakeholder spectrum, thereby disallowing continued use of 
advanced technology dosimeters in these other occupational domains. 
(Commenter 13)
    NRC Response: The NRC agrees with the comment. Under the Agreement 
State Program, the requirements in Sec.  34.47 are categorized as a 
compatibility level C. This means that the essential objectives of a 
program element are adopted by the State to avoid conflicts, 
duplications, or gaps. The manner in which the essential objectives are 
addressed by the Agreement States need not be the same as the NRC's, 
provided the essential objectives are met. Because the essential 
objectives are met for personnel dosimetry (i.e., personnel dosimetry 
is used to determine an individual's dose of record), several Agreement 
States have allowed the use of digital output personnel dosimeters to 
meet the monitoring requirements for industrial radiography and other 
areas. In accepting Issue 1, the NRC intends to expand the availability 
of digital output personnel dosimeters to licensees licensed under 10 
CFR parts 34, 36, and 39 and not impede the current use of the 
dosimetry by Agreement State licensees, including reciprocity 
activities in NRC jurisdictions.
    Currently, several Agreement States allow the use of digital output 
personnel dosimeters to meet the monitoring requirements for industrial 
radiography and other areas. Agreement State regulations for individual 
monitoring of occupational dose do not have to be identical to NRC 
regulations, but need to meet the NRC's health and safety objectives. 
For the most efficient regulation of activities conducted in different 
jurisdictions under reciprocity, personnel dosimetry standards should 
be similar for both NRC and Agreement State licensees.
    Area 3: What experiences or challenges have users encountered in 
the use of digital output personnel dosimeters?
    Comment: During incidents and emergency situations, current 
monitoring badges must be returned to the processor for emergency 
evaluation. This requires that the individual be suspended from 
operations until the results of the processing are received, resulting 
in potential lost wages. Projects may also be put on hold awaiting 
results, resulting in down time, lost revenue, and additional cost and 
time to complete projects. With the new digital dosimeters, readings 
can be immediately downloaded (even at the jobsite), allowing the 
radiographer to potentially return to work and saving time and cost. 
Required reports to the appropriate agency are also provided within a 
much quicker time frame (sometimes as soon as the next day), allowing 
for the issue to be resolved in a much shorter timeframe than with the 
current technology. (Commenters 1, 2, 7, and 10)
    NRC Response: The NRC acknowledges that digital output personnel 
dosimeters may provide enhanced capabilities that allow for expedited 
dosage determinations. Digital output personnel dosimeters do not have 
to be sent offsite for evaluation, making the determination of a 
potential dose for an individual more timely.
    Comment: The benefits of advanced technology dosimeters have been 
apparent in the medical community for nearly a decade. In clinical 
implementation, advanced technology dosimeters have enabled data-rich 
and accurate real-time worker dose monitoring, thereby better informing 
licensees and enhancing the ability to plan and control occupational 
dose. Advanced technology improves monitoring by enabling date/time of 
exposure, providing multiple non-destructive readouts of dose (without 
needing to return the devices to vendors for processing), allowing 
reassignment to other users, and generating better compliance by the 
medical professionals who wear them. (Commenter 13)
    NRC Response: The NRC acknowledges that digital output personnel 
dosimeters may provide enhanced capabilities for dosage measurements 
and has evaluated the technical specifications of these dosimeters in 
various applications and environments. Digital output personnel 
dosimeters have been used by NRC medical licensees successfully for a 
number of years without any reported issues. Additionally, several 
Agreement States have allowed the use of these dosimeters in medical 
and other areas, including industrial radiography, for years without 
any incidents noted by the NRC.

[[Page 3120]]

III. Reasons for Consideration

    The NRC will consider Issue 1 in the rulemaking process.
    Digital output personnel dosimetry does not currently meet the 
requirements for personnel dosimetry in 10 CFR parts 34, 36, and 39. 
The NRC's position has been that personnel dosimetry used to meet the 
requirements in these parts must be processed as described in Sec.  
20.1501(d). In evaluating the issues raised in this petition, the NRC 
reviewed the technical specifications of currently available digital 
output personnel dosimeters to determine whether the use of this 
personnel dosimetry design would meet the NRC's health and safety 
objectives. The NRC determined that these dosimeters meet or exceed the 
environmental requirements (e.g., temperature, humidity) and dose 
range, and have the quality control necessary for use in industrial 
radiographic, irradiator, and well logging operations. From a 
literature search of technical journals, the NRC did not find any 
articles that highlighted generic performance problems with the use of 
these dosimeters. Digital output personnel dosimeters have been used 
successfully by NRC licensees in other operational areas, by several 
Agreement State licensees in all areas including industrial 
radiography, and internationally in multiple applications. Based on 
these findings, the NRC determined that rulemaking should be initiated 
to allow the use of digital output personnel dosimeters to satisfy the 
personnel dosimetry requirements in 10 CFR parts 34, 36, and 39.

IV. Reasons for Denial

    The NRC is denying Issue 2 raised by the petitioners.
    Since the promulgation of 10 CFR part 34, there have been several 
technological advances in dosimetry for personnel monitoring during 
industrial radiographic operations. On September 19, 2017, the NRC 
issued RIS 2017-06, ``NRC Policy on Use of Combination Dosimetry 
Devices during Industrial Radiographic Operations'' (ADAMS Accession 
No. ML16137A077), clarifying that licensees may use dual-function EADs 
(also referred to as combination dosimetry devices in the RIS) for 
meeting the direct reading dosimeter and the alarm ratemeter device 
requirements specified in Sec.  34.47(a). The RIS explained that dual-
function EADs have been used routinely and reliably for over 25 years 
as a secondary dosimeter in the operating environment of nuclear power 
reactors with no subsequent degradation in personnel safety. This 
determination was based on the NRC staff not finding any evidence of 
generic performance problems with EADs in an industrial setting in a 
review of the recent literature and NRC documents, or in discussions 
with NRC, military, and industry health physicists with EAD experience. 
Further, the NRC staff did not identify any adverse trends that would 
preclude using EADs as a dual-function device in industrial radiography 
operations to meet the requirements in Sec.  34.47(a). The many years 
of operational experience in the reactor arena have demonstrated that 
EADs are effective for monitoring dose and dose rate, as well as for 
providing visual/audible alarms for preset thresholds. Therefore, the 
NRC determined, as stated in the RIS, that licensees may use dual-
function EADs for meeting the direct reading dosimeter and the alarm 
ratemeter device requirements specified in Sec.  34.47(a).
    The NRC determined that RIS 2017-06 provides clarification 
regarding the issue raised by the petitioners with respect to the use 
of dual-function EADs and, therefore, rulemaking is not necessary to 
address this petition request.

V. Conclusion

    For the reasons cited in this document, the NRC is denying the 
petitioners' request to amend the NRC's regulations to authorize the 
use of dual-function EADs to satisfy the requirements in Sec.  34.47(a) 
(Issue 2); the NRC finds that rulemaking is not necessary to address 
this issue. The RIS 2017-06 provides clarification that dual-function 
EADs may be used to satisfy the requirements in Sec.  34.47(a).
    The NRC will consider in the rulemaking process the petitioners' 
request to amend the NRC's regulations to authorize the use of digital 
output personnel dosimeters to satisfy the requirements in Sec.  
34.47(a) (Issue 1). As noted in Section III. ``Reasons for 
Consideration,'' in this document, the NRC determined that these 
dosimeters meet or exceed the technical specifications for use in 
radiographic operations. Additionally, digital output personnel 
dosimeters have been used successfully by NRC licensees in other 
operational areas, by several Agreement State licensees in all areas 
including industrial radiography, and internationally in multiple 
applications.
    The review that NRC staff performed regarding the use of digital 
output dosimeters included the environmental and technical 
considerations for use by 10 CFR part 36 and 39 licensees. Based on 
these findings, the NRC intends to expand the scope of this rulemaking 
to address requirements for personnel dosimetry in 10 CFR parts 36 and 
39.
    The NRC will conduct rulemaking on Issue 1 raised by the 
petitioners as resources become available.
    The NRC tracks the status of all rules and PRMs on its website at 
https://www.nrc.gov/about-nrc/regulatory/rulemaking/rules-petitions.html. The public may monitor the docket for the rulemaking to 
address Issue 1 on the Federal rulemaking website, http://www.regulations.gov, by searching on Docket ID NRC-2019-0031. In 
addition, the Federal rulemaking website allows members of the public 
to receive alerts when changes or additions occur in a docket folder. 
To subscribe: (1) Navigate to the docket folder (NRC-2019-0031); (2) 
click the ``Email Alert'' link; and (3) enter an email address and 
select the frequency for email receipts (daily, weekly, or monthly). 
Publication of this document in the Federal Register closes Docket ID 
NRC-2016-0182 for PRM-34-7.

    Dated at Rockville, Maryland, this 5th day of February, 2019.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2019-01792 Filed 2-8-19; 8:45 am]
 BILLING CODE 7590-01-P