[Federal Register Volume 68, Number 86 (Monday, May 5, 2003)]
[Proposed Rules]
[Pages 23618-23620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10967]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 86 / Monday, May 5, 2003 / Proposed 
Rules  

[[Page 23618]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 20

[Docket No. PRM-20-25]


Sander C. Perle, ICN Worldwide Dosimetry Service, Receipt of 
Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; notice of receipt.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing for 
public comment a notice of receipt of a petition for rulemaking, dated 
March 19, 2003, which was filed with the Commission by Sander C. Perle, 
Technical Director of ICN Worldwide Dosimetry Service. The petition was 
docketed by the NRC on March 26, 2003, and has been assigned Docket No. 
PRM-20-25. The petitioner requests 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 petitioner also requests that the 
definition of Individual monitoring devices (individual monitoring 
equipment) be revised to include ``electronic dosimeters, optically 
stimulated dosimeters'' as examples of certain devices.

DATES: Submit comments by July 21, 2003. Comments received after this 
date will be considered if it is practical to do so, but the Commission 
is able to assure consideration only for comments received on or before 
this date.

ADDRESSES: You may submit comments by any one of the following methods. 
Please include ``PRM-20-25'' in the subject line of your comments. 
Comments submitted in writing or in electronic form will be made 
available to the public in their entirety on the NRC rulemaking Web 
site. Personal information will not be removed from your comments.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us 
directly at (301) 415-1966. You may also submit comments via the NRC's 
rulemaking Web site at http://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail 
[email protected].
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone 
(301) 415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
(301) 415-1101.
    Publicly available documents related to this petition may be 
examined and copied for a fee at the NRC's Public Document Room (PDR), 
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland. Selected documents, including comments, can be 
viewed and downloaded electronically via the NRC rulemaking Web site at 
http://ruleforum.llnl.gov.
    Publicly available documents created or received at the NRC after 
November 1, 1999, are available electronically at the NRC's Electronic 
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this 
site, the public can gain entry into the NRC's Agencywide Document 
Access and Management System (ADAMS), which provides text and image 
files of NRC's public documents. If you do not have access to ADAMS or 
if there are problems in accessing the documents located in ADAMS, 
contact the NRC's PDR Reference staff at 1-800-397-4209, 301-415-4737 
or by e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules and 
Directives Branch, Division of Administrative Services, Office of 
Administration, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001, Telephone: 301-415-7163 or Toll Free: 800-368-5642.

SUPPLEMENTARY INFORMATION: 

The Petitioner

    The petitioner is the Technical Director of ICN Worldwide Dosimetry 
Service. According to the petitioner, ICN Worldwide Dosimetry Service 
processes approximately 5 million dosimeters annually (film, TLD and 
CR39).

The Petitioner's Request

    The petitioner requests that the NRC amend its regulations in 10 
CFR Part 20 to require that all dosimeters used to determine the 
radiation 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 receive personnel dosimetry 
accreditation from the National Voluntary Laboratory Accreditation 
Program (NVLAP) of the National Institute of Standards and Technology. 
The petitioner also requests that the definition of Individual 
monitoring devices (individual monitoring equipment) be revised to 
include ``electronic dosimeters'' and ``optically stimulated 
dosimeters'' as examples of certain devices for the assessment of dose 
equivalent or to comply with Sec.  20.1202.

Justification for the Petition

    The petitioner states that the current wording of Sec.  20.1501(c) 
precludes the testing and accreditation requirements for an electronic 
dosimeter (currently excludes ``processed'' dosimeters). The petitioner 
states 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) doesn't appear to include the definition of an 
electronic dosimeter, nothing prohibits a licensee from using a an 
electronic dosimeter as a dose of record. He states that the NRC's 
philosophy is that the NRC onsite

[[Page 23619]]

inspector can assess the validity of the electronic dosimeter quality 
assurance program. The petitioner believes that the NVLAP onsite 
assessor 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 they do for 
all other NVLAP accredited whole body dosimeters.
    The petitioner states that the current wording of Sec.  20.1501(c) 
precludes the testing and accreditation requirements for an extremity 
dosimeter (finger or wrist dosimeter). He states that because Sec.  
20.1201, Occupational dose limits for adults, specifies a dose limit, 
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 states that NVLAP has accredited extremity 
dosimeters per Standard ANSI N13.32-1995, Performance Testing of 
Extremity Dosimeters for the past 8 years. The petitioner believes that 
there is no reason to continue excluding extremity dosimeters from 
requiring accreditation.
    The petitioner notes that the NRC participated in an Electronic 
Dosimetry Workshop on October 14 -16, 1998 (Journal of Research of the 
National Institute of Standards and Technology, Volume 103, No. 4, 
July-August 1998). The petitioner states that the ``Conference Report'' 
(documenting that workshop) concludes that electronic dosimeters need 
to be measured by the same standard as the passive dosimeters currently 
in use and defines the electronic dosimeter as a processed dosimeter.

    The petitioner presents the following as a summary of the 
Conference Report:
    1. A search for consensus, among recommendations, and was 
intended to result in the broad acceptance of the electronic 
dosimeter for dose or record.
    2. Ensure that the electronic dosimeter is measured by the same 
standard as the passive dosimeters currently in use.
    3. This focused on defining the electronic dosimeter as a 
processed dosimeter in order to confirm that it fit the requirements 
of 10 CFR Part 20 for processed dosimeters.
    4. It is clear that a process is used by the electric dosimeter 
to change from radiation energy deposited in the detector to a dose 
quantity representing risk to the worker.
    5. The user has an important role in routine testing and/or 
calibration of the electronic dosimeters and this may be the point 
at which quality control activities (accreditation) should be 
addressed.

    The petitioner believes that requiring NVLAP Accreditation 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.

The Petitioner's Suggested Changes

    1. The definition for Individual monitoring devices (individual 
monitoring equipment) Is revised to read as follows:


Sec.  20.1003  Definitions.

* * * * *
    Individual monitoring devices (individual monitoring equipment) 
means devices designed to be worn by a single individual for the 
assessment of dose equivalent, used by licensees to comply with Sec.  
20.1201, such as film badges, thermoluminescent dosimeters (TLDs), 
pocket ionization chambers, electronic dosimeters, optically stimulated 
dosimeters and person (``label'') air sampling devices.
* * * * *
    2. Section 20.1501(c) is revised to read as follows:


Sec.  20.1501  General.

* * * * *
    (c) All personnel dosimeters used to determine the radiation dose 
and that are used by licensees to comply with 10 CFR 20.1201, with 
other applicable provisions of this chapter, or with conditions 
specified in a license, must be processed and/or evaluated by a 
dosimetry processor.
* * * * *

The Petitioner's Conclusions

    The petitioner states that when an occupationally exposed worker 
wears a dosimeter, the worker expects that the dosimeter will measure 
and report their dose as accurately and precisely as technically 
feasible. This requires that the dosimeter be capable of performing 
adequately in the radiation environment that the worker is exposed to. 
Therefore, a dosimeter must be able to respond adequately in varying 
radiation environments; i.e., varying gamma, Beta, x-ray and neutron 
fields of varying dose rates and geometry. The petitioner states that 
requiring NVLAP accreditation assures the worker, the licensee, 
management, and the NRC (as well as state regulators) that the 
dosimeter worn performs as expected. NVLAP accreditation requires both 
the testing to varying radiation types, energies, dose range and 
angularity. NVLAP accreditation also provides onsite assessment of the 
entire Quality System. The petitioner believes that while NVLAP 
accreditation does not give 100 percent assurance that the licensee is 
performing to the best of its ability, it does provide a degree of 
assurance that any serious programmatic deficiencies that exist are 
documented and NVLAP follow-up is initiated to ensure that these 
deficiencies are corrected. The most appropriate entity to assess a 
dosimetry program is an NVLAP technical expert, not an NRC on-site 
inspector.
    The petitioner states that the inspector can assess a dosimetry 
program, review the NVLAP report, and then take appropriate action to 
ensure that the licensee does comply with all requirements. Without 
these suggested amendments, there is no accredited testing performed 
for either extremity dosimeters or electronic dosimeters. There is no 
required onsite assessment by NVLAP. The petitioner believes that there 
is no standard that is required to be met. This does not serve the 
licensee well, and more importantly, leaves the workers with a dose 
that has no support from any recognized U.S. or international standard. 
The petitioner states that the NRC would be better prepared to stand 
behind a dose that is submitted as dose of record, and ultimately the 
dose recorded would stand a better chance of being accepted in the 
event of litigation. Litigation and valid dosimetry drives the American 
Nuclear Insurers (ANI) to require any nuclear power plant worker who is 
expected to exceed 100 mrem in a calendar year, to wear two dosimeters 
(independent technology) to demonstrate that the dose of record can be 
substantiated using these varying technologies. The validity of the 
dose assigned logically requires that whatever dosimeter is used to 
meet Sec.  20.1201, it must meet recognized standards. The petitioner 
states that the NRC has stated this in many venues, most notably the 
Electronic Dosimetry Workshop, documented in the Conference Report, 
Electronic Dosimetry Workshop, Gaithersburg, MD,

[[Page 23620]]

October 14-16, 1998, Journal of Research of the National Institute of 
Standards and Technology, Volume 103, No. 4, July-August 1998. The 
petitioner believes that it is time for the NRC to implement the 
necessary changes to Sec.  20.1501(c).

    Dated at Rockville, Maryland, this 29th day of April 2003.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 03-10967 Filed 5-2-03; 8:45 am]
BILLING CODE 7590-01-P