[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Proposed Rules]
[Pages 2577-2580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-778]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 20

[Docket No. PRM-20-25]


Sander C. Perle, ICN Worldwide Dosimetry; Denial of Petition for 
Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; Denial.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition 
for rulemaking submitted by Sander C. Perle, ICN Worldwide Dosimetry 
(now Global Dosimetry Solutions, Inc.) (PRM-20-25). The petitioner 
requested that the NRC amend its regulations to require that any 
dosimeter, without exception, that is used to report dose of record and 
demonstrate compliance with the dose limits specified in the 
Commission's regulations be processed and evaluated by a dosimetry 
processor holding accreditation from the National Voluntary Laboratory 
Accreditation Program (NVLAP) of the National Institute of Standards 
and Technology; the definition of ``Individual monitoring devices'' 
(individual monitoring equipment) be revised to mean any device used by 
licensees to show compliance with the Commission's regulations; and 
``electronic dosimeters and optically stimulated dosimeters'' be added 
as additional examples of individual monitoring devices.

ADDRESSES: Copies of the petition for rulemaking, the public comments 
received, and the NRC's letter to the petitioner are available for 
public inspection and/or copying in the NRC Public Document room, 11555 
Rockville Pike, Rockville, Maryland. These same documents are also 
available on the NRC's rulemaking Web site at http://ruleforum.llnl.gov. For information about the interactive rulemaking 
Web site, contact Carol Gallagher, (301) 415-5905, e-mail: [email protected].
    The NRC maintains an Agencywide Document Access and Management 
System (ADAMS), which provides text and image files of NRC's public 
documents. These documents may be accessed through the NRC's Public 
Electronic Reading Room on the Internet at http://www.nrc.gov/reading-rm/adams.html. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC 
Public Document Room Reference staff at 1-800-397-4209, 301-415-4737, 
or by e-mail to [email protected]. Note: Public access to documents, 
including access via ADAMS and the PDR, has been temporarily suspended 
so that security reviews of publicly available documents may be 
performed and potentially sensitive information removed. However, 
access to the documents identified in this Federal Register continues 
to be available through the rulemaking Web site at http://ruleforum.llnl.gov, which was not affected by the ADAMS shutdown. 
Please check with the listed NRC contact concerning any issues related 
to document availability.

FOR FURTHER INFORMATION CONTACT: Torre Taylor, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: (301) 415-7900; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 

The Petition

    On May 5, 2003 (68 FR 23618), the NRC published a notice of receipt 
of a petition for rulemaking filed by Sander C. Perle, ICN Worldwide 
Dosimetry (now Global Dosimetry Solutions, Inc.). The petitioner 
requested that the NRC amend its regulations to require that any 
dosimeter, without exception, that is used to report dose of record and 
demonstrate compliance with the dose limits specified in the 
Commission's regulations be processed and evaluated by a dosimetry 
processor holding accreditation from NVLAP; the definition of 
``Individual monitoring devices'' [in 10 CFR 20.1003] (hereafter, ``10 
CFR Section'' referred to as Sec. ) (individual monitoring equipment) 
be revised to mean any device used by licensees to show compliance with 
Sec.  20.1201; and ``electronic dosimeters and optically stimulated 
dosimeters'' be added as additional examples of individual monitoring 
devices in the definition of ``Individual monitoring devices.''
    The petitioner stated that the current wording of Sec.  
20.1501(copyright)) precludes testing and accreditation requirements 
for an electronic dosimeter. The petitioner also stated that today's 
electronic dosimeters use multiple microprocessors that include many 
complex user input parameters that ultimately affect the final dose 
and/or dose rate reported. The dose determined from an electronic 
dosimeter is a ``processed'' dose. The electronic dosimeter requires 
that the licensee program the dosimeter to respond to various spectra, 
based on the calibration and other licensee set parameters. According 
to the petitioner, the NRC's position is that, because the current 
Sec.  20.1501(c) does not appear to include

[[Page 2578]]

the definition of an electronic dosimeter, nothing prohibits a licensee 
from using an electronic dosimeter to establish a dose of record. The 
petitioner states that the NRC's philosophy is that the NRC onsite 
inspector can assess the validity of the electronic dosimeter quality 
assurance program. The petitioner believes that the NVLAP onsite 
assessor [the NVLAP onsite assessor who inspects the facility 
requesting accreditation] is the most appropriate individual to assess 
a facility's quality assurance program, and to determine if the 
electronic dosimeter is capable of measuring and reporting accurate and 
precise dose results for workers in a specific radiation work 
environment, as the NVLAP onsite assessor does for all other NVLAP 
accredited whole body dosimeters.
    The petitioner also stated that the current wording of Sec.  
20.1501(c) precludes testing and accreditation requirements for an 
extremity dosimeter (finger or wrist dosimeter). The petitioner states 
that because Sec.  20.1201, Occupational dose limits for adults, 
specifies a dose limit, including the annual limits to the extremities, 
which are a shallow dose equivalent of 50 rems (0.5 Sv) to the skin or 
to an extremity, it would seem logical that the dosimeter used to make 
this dose determination should be accredited through the same process 
as a whole body dosimeter. The petitioner indicated that NVLAP has 
accredited [processors of] extremity dosimeters per American National 
Standards Institute (ANSI) standard N13.32-1995, ``Performance Testing 
of Extremity Dosimeters,'' for the past 8 years. The petitioner 
believes that there is no reason to continue to exclude [processors of] 
extremity dosimeters from required NVLAP accreditation.
    The petitioner believes that requiring NVLAP accreditation [for the 
use] of electronic dosimeters provides an unbiased third-party 
evaluation and recognition of performance, as well as expert technical 
guidance to upgrade laboratory performance. NVLAP accreditation 
signifies that a laboratory has demonstrated that it operates in 
accordance with NVLAP management and technical requirements pertaining 
to quality systems; personnel; accommodation and environment; test and 
calibration methods; equipment; measurement traceability; sampling; 
handling of test and calibration items; and test and calibration 
reports. NVLAP accreditation does not imply any guarantee 
(certification) of laboratory performance or test/calibration data; it 
is solely a finding of laboratory competence.

Public Comments on the Petition

    The notice of receipt of the petition for rulemaking invited 
interested persons to submit comments. The petition was docketed as 
PRM-20-25. The petition was published in the Federal Register on May 5, 
2003 (68 FR 23618), for a 75-day comment period. The comment period 
closed on July 21, 2003. NRC received nine comment letters from 
utilities, industry, the public, and a State radiation control program. 
NRC also received three comment letters from the petitioner, in 
response to public comments NRC received regarding the petition. Six 
commenters recommended that NRC deny the petition, three commenters 
supported the petition, but with substantial changes, and three 
comments were received from the petitioner responding to comments that 
the NRC received on the petition. The majority of the commenters 
opposed the petition. Two commenters agreed with the intent of the 
petition; however, they had concerns with the proposed regulatory 
language. Several commenters noted that the proposed revision would 
require NVLAP accreditation [of processors] for all dosimeters, 
including dosimeters that are used as backup dosimeters. [Note that the 
terms ``secondary'' and ``backup dosimetry'' are used by the 
commenters. NRC does not have a definition for ``secondary'' or 
``backup dosimetry.''] Some commenters indicated that electronic 
dosimeters are control devices for real-time exposure information and 
should not be subject to NVLAP accreditation for the processor. The 
concern is that licensees might then issue only one NVLAP accredited 
dosimeter and remove the redundancy now in place with wearing a second 
dosimeter.
    Cost was a major issue with the commenters. One commenter believes 
the proposed revision could force a licensee to hire a third party to 
oversee and implement its use of electronic dosimeters. Others 
commented that NVLAP testing costs would at least double. Some 
commenters believe that the cost of accreditation does not warrant the 
benefit of having all dosimeters evaluated by a NVLAP accredited 
dosimetry processor. Several commenters believed that the proposed 
revision would impose additional burden that is unnecessary and 
unjustified.
    One commenter questioned the petitioner's statement that electronic 
dosimetry is processed. One commenter questioned the availability of a 
viable standard for electronic dosimetry upon which to base NVLAP 
testing.
    Regarding the petitioner's proposed change to require NVLAP 
accreditation for processors of extremity dosimetry, one commenter 
indicated that the current standard for extremity dosimetry, ANSI/
Health Physics Society (HPS) N13.32-1995, ``Performance Testing of 
Extremity Dosimeters,'' is undergoing a major revision, and that NRC 
should defer any rulemaking on this issue until the revision of this 
standard is completed.
    One commenter believes that the proposed revision represents a 
backfit requirement and that it would impose new requirements on 
licensees with an additional burden to revise programs and procedures, 
and to provide training. Many commenters believe that the current 
programs for monitoring and recording occupational radiation dose are 
adequate to assure protection of worker health and safety and did not 
believe the petitioner provided information to the contrary. One 
commenter did not believe that the petition described a regulatory 
problem or issue in the current program and that the proposed revision 
only provided an enhancement to the regulations. One commenter stated 
that: ``There are certain situations where NVLAP accreditation is not 
available for all neutron fields. * * * the proposal would leave no 
compliance option for licensees with radiation fields beyond the 
standard NVLAP parameters.'' Another commenter indicated that the 
proposed revision would empower NVLAP to dictate to the licensee the 
categories for which testing would be required.
    The petitioner provided three comments in response to public 
comments that were submitted to NRC, which are summarized as follows. 
The petitioner stated that the intent of the petition is for the 
proposed revisions to apply only to the primary dosimeter, and not to 
the secondary dosimeter. [Note that the terms ``primary'' and 
``secondary'' are used by the petitioner; NRC does not have a 
definition of these terms in its regulations. The NRC staff understands 
that the petitioner means the ``primary'' dosimeter as the dosimeter 
that provides the ``dose of record'' and that the ``secondary'' 
dosimeter is the ``backup'' dosimeter.] The petitioner disagreed with a 
comment that no compliance options are left for licensees with 
radiation fields beyond NVLAP parameters. A facility would test in 
those radiation categories that are representative of the radiation 
field to which its employees are exposed. The petitioner also stated

[[Page 2579]]

that if the petition was not approved, the extremity ring or wrist 
dosimeters would continue to be worn with no requirement that they be 
tested under any proficiency testing program.

Reasons for Denial

    After reviewing the petition and the public comments, the NRC is 
denying the petition. NRC has determined that the current NRC 
regulations are adequate to protect worker and public health and 
safety. The NRC is denying the petition because there is insufficient 
evidence that it solves a regulatory problem or improves health and 
safety. The additional requirements would be an increase in burden for 
licensees who have their own accreditation, and for processors, without 
a commensurate benefit of increased protection of worker health and 
safety. The increase in burden would be from the additional resources 
for the NVLAP accreditation process, which includes the accreditation 
fee, as well as the staff time to go through the accreditation process, 
which includes an on-site assessment of the facility. The accreditation 
is renewed every two years, so this is not a one time cost. This would 
be an imposed burden with no additional benefit in health and safety.
    Discussion of the specific requests of the petitioner follows. The 
NRC is denying the petitioner's request that the NRC amend its 
regulations to require that any dosimeter, without exception, that is 
used to report dose of record and demonstrate compliance with the dose 
limits specified in the Commission's regulations be processed and 
evaluated by a dosimetry processor holding accreditation from NVLAP. 
The NRC does not agree with the petitioner that electronic dosimeters 
are processed. Although not defined in the regulations, 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 or thermoluminescent (TLD) dosimetry to obtain the dose 
information. With film or TLD dosimetry, the quality of the processing 
is dependent on the competence of the processor, and not on the 
dosimeter design. Quality is built into the design of dosimeters that 
do not require processing. Additionally, these devices are calibrated 
on a routine basis to ensure the device is responding properly. The NRC 
is not aware of any problem with the current calibration processes, and 
the petitioner has not provided any evidence of an existing deficiency 
in the calibration process. The NRC reviews licensees' calibration 
programs during routine inspections. Subjecting processors to NVLAP 
accreditation for dosimeters that do not require processing will not 
improve the reliability of these dosimeters.
    Regarding the petitioner's request to remove the exception for 
NVLAP accreditation for extremity dosimetry, currently allowed in Sec.  
20.1501(c), the NRC agrees in principle that it is a good idea to 
include extremity dosimeters that require processing in the requirement 
for NVLAP accreditation for processors. However, the ANSI and HPS 
standard for extremity dosimeters, ANSI/HPS N13.32-1995, ``Performance 
Testing of Extremity Dosimeters,'' is undergoing a major revision. The 
petitioner has provided no evidence that there is a current health and 
safety problem and much of the industry is voluntarily obtaining NVLAP 
accreditation for processing of extremity dosimetry. Consequently, the 
NRC believes it is premature to remove this regulatory exception. 
Therefore, NRC is not taking regulatory action on this issue.
    Granting the petitioner's request to revise the definition of 
``Individual monitoring device'' in Sec.  20.1003 to add ``used by 
licensees to show compliance with Sec.  20.1201'' would result in 
unintended requirements. There are many devices used to show 
compliance, such as alarming ratemeters, chirpers, and lapel air 
samplers. The petition, if granted, would result in a requirement that 
users of essentially all listed types of dosimeters would go through a 
process that is accredited by NVLAP. Many individual monitoring devices 
do not require processing to obtain the dose information, such as 
alarming ratemeters, chirpers, etc., and NVLAP accreditation will not 
improve the reliability of the devices. The petitioner also proposed 
adding two more examples, electronic dosimeters and optically 
stimulated dosimeters, in the definition of ``Individual monitoring 
device.'' The current examples in the definition of ``Individual 
monitoring device'' are not meant to be all inclusive, and adding two 
more examples will not add any safety value and does not justify a 
rulemaking.
    This petition must also be evaluated with respect to NRC's 
backfitting requirements. Backfit is defined, in part, as the 
modification of, or addition to, the procedures or organization 
required to design, construct or operate a facility; any of which may 
result from a new or amended provision in the Commission rules or the 
imposition of a regulatory staff position interpreting the Commission 
rules that is either new or different from a previously applicable 
staff position (See Sec. Sec.  50.109, 70.76, 72.62, and 76.76). The 
NRC requires backfitting only when it determines that there is a 
substantial increase in the overall protection of the public health and 
safety or the common defense and security to be derived from the 
backfit, and that the direct and indirect costs of implementation are 
justified in view of this increased protection.
    The petitioner's proposed action would be considered a backfit 
because it would require licensees to modify their procedures and 
organization to operate a facility, and the proposed action does not 
fall within any of the exceptions in the above referenced sections of 
the regulations. The petition, if granted, would require that any 
dosimeter that could possibly be used to report the dose of record and 
demonstrate compliance with the dose limits specified in the NRC 
regulations be processed and evaluated by a dosimetry processor holding 
NVLAP accreditation. This would require an expansion of the 
requirements for the dosimeters with an increased cost and burden to 
licensees, without a commensurate benefit in health and safety or the 
common defense and security.
    After reviewing the proposed actions, NRC believes that the 
proposed actions would not pass a detailed backfit analysis. There is 
insufficient evidence that the petition, if granted, would solve a 
regulatory problem or improve health and safety. No data were provided 
by the petitioner, nor did the NRC find any data, to show that existing 
regulations are inadequate to protect health and safety. The increase 
in cost to licensees, without a commensurate health and safety benefit 
or the common defense and security, does not warrant granting this 
petition.
    In conclusion, there is insufficient evidence that the petition 
solves a regulatory problem or improves health and safety. If the 
petition were granted, there would be a large increase in burden to 
licensees that is unjustified without a health and safety concern. 
Therefore, the NRC has determined that existing NRC regulations are 
adequate to provide the basis for reasonable assurance that worker 
health and safety are protected.
    For the reasons cited in this document, the NRC denies this 
petition.

    Dated at Rockville, Maryland, this 23 day of December, 2004.


[[Page 2580]]


    For the Nuclear Regulatory Commission.
Ellis W. Merschoff,
Acting, Executive Director for Operations.
[FR Doc. 05-778 Filed 1-13-05; 8:45 am]
BILLING CODE 7590-01-P