[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]
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Proposed Rules
Federal Register
________________________________________________________________________
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]
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