[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Notices]
[Pages 15173-15175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5932]
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NUCLEAR REGULATORY COMMISSION
Interim Regulatory Guide: Issuance, Availability
The U.S. Nuclear Regulatory Commission (NRC) has issued an interim
revision to an existing guide in the agency's Regulatory Guide Series.
This series has been developed to describe and make available to the
public such information as methods that are acceptable to the NRC staff
for implementing specific parts of the agency's regulations, techniques
that the staff uses in evaluating specific problems or postulated
accidents, and data that the staff needs in its review of applications
for permits and licenses.
The revised guide, entitled ``Quality Assurance for Radiological
Monitoring Programs (Inception Through Normal Operations to License
Termination)--Effluent Streams and the Environment,'' is identified as
Interim Revision 2 of Regulatory Guide 4.15. Like its predecessor, this
interim revision describes a method that the NRC staff considers
acceptable for use in designing and implementing programs to ensure the
quality of the results of measurements of radioactive materials in the
effluents from, and environment outside of, facilities that process,
use, or store radioactive materials during all phases of the facility's
life cycle. Quality assurance (QA) is a fundamental expectation of
Title 10, ``Energy,'' of the Code of Federal Regulations (10 CFR) for
items and activities that are relied on to protect the health and
safety of the public and the environment.
This interim guide serves as a final regulatory guide for, and may
be used by applicants and licensees of nuclear power reactors. It also
presents draft NRC staff positions on a method for designing and
implementing QA programs for use by non-nuclear power reactor
applicants and licensees subject to the agency's QA requirements. The
NRC staff seeks public comments on this regulatory guide with respect
to its application to such licensees. The NRC staff will issue this
guide in final form after resolving any comments received during the
public comment period.
Interim Revision 2 of Regulatory Guide 4.15 specifically applies to
facilities for which NRC regulations require routine monitoring of
radioactive effluents to the environment, and particularly those
facilities licensed under the following regulations:
10 CFR Part 50, ``Domestic Licensing of Production and
Utilization Facilities''
10 CFR Part 52, ``Licenses, Certifications, and Approvals
for Nuclear Power Plants''
10 CFR Part 61, ``Licensing Requirements for Land Disposal
of Radioactive Waste''
10 CFR Part 72, ``Licensing Requirements for the
Independent Storage of Spent Nuclear Fuel, High-Level Radioactive
Waste, and Reactor-Related Greater Than Class C Waste''
10 CFR Part 76, ``Certification of Gaseous Diffusion
Plants''
The guidance may also apply to other NRC-licensed facilities, for
which the agency may impose specific license conditions for effluent or
environmental monitoring, as deemed necessary to ensure the health and
safety of the public and the environment, including those licensed
under the following regulations:
10 CFR Part 30, ``Rules of General Applicability to
Domestic Licensing of Byproduct Material''
10 CFR Part 40, ``Domestic Licensing of Source Material''
10 CFR Part 70, ``Domestic Licensing of Special Nuclear
Material''
[[Page 15174]]
Finally, radiological standards for occupational workers and
members of the public are codified in 10 CFR Part 20, ``Standards for
Protection Against Radiation.''
As used in the context of Interim Revision 2 of Regulatory Guide
4.15, QA comprises all those planned and systematic actions that are
necessary to provide adequate confidence in the assessment of
monitoring results. Quality control (QC) comprises those QA actions
that provide a means to measure and control the characteristics of
measurement equipment and processes to meet established standards; QA
includes QC. Interim Revision 2 of Regulatory Guide 4.15 makes no
further effort to distinguish those elements that may be considered QC
from those composing QA.
Quality assurance is necessary to ensure that all radiological and
nonradiological measurements that support the radiological monitoring
program are reasonably valid and of a defined quality. These programs
are needed (1) to identify deficiencies in the sampling and measurement
processes and report them to those responsible for these operations so
that corrective action can be taken, and (2) to obtain some measure of
confidence in the results of the monitoring programs to assure the
regulatory agencies and the public that the results are valid. All
steps of the monitoring process (for example, sampling, shipment of
samples, receipt of samples in the laboratory, preparation of samples,
radiological measurements, data reduction, data evaluation, and
reporting of the measurement and monitoring results) should involve QA.
Interim Revision 2 of Regulatory Guide 4.15 presents more complete
and extensive guidance on QA for facilities where radiological effluent
or environmental monitoring is required by NRC regulations.\1\ However,
this guidance does not address all topics and elements that a
facility's QA program may require (such as requirements of Appendix B
to 10 CFR Part 50 for nuclear power plants or 10 CFR 76.93 for gaseous
diffusion uranium enrichment facilities).
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\1\ While not specific to QA, the following regulatory guides
also address measurements of radioactive materials in effluents and
the environment:
Regulatory Guide 1.21, ``Measuring, Evaluating, and
Reporting Radioactivity in Solid Wastes and Releases of Radioactive
Materials in Liquid and Gaseous Effluents from Light-Water-Cooled
Nuclear Power Plants.''
Regulatory Guide 4.1, ``Programs for Monitoring
Radioactivity in the Environs of Nuclear Power Plants.''
Regulatory Guide 4.14, ``Radiological Effluent and
Environmental Monitoring at Uranium Mills.''
Regulatory Guide 4.16, ``Monitoring and Reporting
Radioactivity in Releases of Radioactive Materials in Liquid and
Gaseous Effluents from Nuclear Fuel Processing and Fabrication
Plants and Uranium Hexafluoride Production Plants.''
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In addition, although Interim Revision 2 of Regulatory Guide 4.15
offers significant improvements in programmatic and technical guidance
for QA and QC for radioactive effluent and environmental monitoring, it
does not impose any new or additional requirements. Rather, this
interim revision incorporates updated scientific and regulatory
concepts concerning radioanalytical QA, which the NRC and industry have
previously published not as requirements, but as good practices.
Licensees may continue to use Revision 1 of Regulatory Guide 4.15,
dated February 1979, if they so choose. Consequently, no backfit, as
defined in 10 CFR 50.109, ``Backfitting,'' is either intended or
implied.
The NRC previously solicited public comment on Revision 2 of
Regulatory Guide 4.15 by issuing Draft Regulatory Guide DG-4010 in
November 2006. The public comment period closed on December 17, 2006,
and the staff has appropriately addressed all comments received. The
staff's responses to all stakeholder comments received are available in
the NRC's Agencywide Documents Access and Management System (ADAMS) at
http://www.nrc.gov/reading-rm/adams.html, under Accession
ML070380010.
However, at the time of issuance, the NRC erroneously described
Draft Regulatory Guide DG-4010 as applicable only to nuclear power
reactor applicants and licensees. The NRC staff intended that this
regulatory guide apply to all applicants and licensees subject to the
agency's QA requirements.
Accordingly, the NRC is now issuing Revision 2 of Regulatory Guide
4.15 as an interim regulatory guide, which is applicable only to
nuclear power reactor applicants and licensees. The NRC staff is also
soliciting comments on this interim guide with respect to its
application to non-nuclear power reactor applicants and licensees
subject to the agency's QA requirements. The NRC staff will issue this
guide in final form after resolving any comments received during the
public comment period.
Comments on this interim revision may be accompanied by relevant
information or supporting data. Please mention Interim Revision 2 of
Regulatory Guide 4.15 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 through the NRC's Agencywide Documents
Access and Management System (ADAMS). Personal information will not be
removed from your comments. You may submit comments by any of the
following methods.
Mail comments to: Rulemaking, Directives, and Editing Branch,
Office of Administration, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001.
E-mail comments to: [email protected]. 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 A. Gallagher (301)
415-5905; e-mail [email protected].
Hand-deliver comments to: Rulemaking, Directives, and Editing
Branch, Office of Administration, U.S. Nuclear Regulatory Commission,
11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and
4:15 p.m. on Federal workdays.
Fax comments to: Rulemaking, Directives, and Editing Branch, Office
of Administration, U.S. Nuclear Regulatory Commission at (301) 415-
5144.
Requests for technical information about Interim Revision 2 of
Regulatory Guide 4.15 may be directed to Dr. George E. Powers, at (301)
415-6212 or [email protected].
Comments would be most helpful if received by May 29, 2007.
Comments received after that 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. Although a time limit is given,
comments and suggestions in connection with items for inclusion in
guides currently being developed or improvements in all published
guides are encouraged at any time.
Regulatory guides are available for inspection or downloading
through the NRC's public Web site at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/. In addition, Interim Revision 2 of Regulatory
Guide 4.15 is available for inspection or downloading through ADAMS at
http://www.nrc.gov/reading-rm/adams.html, under Accession
ML070380006.
Interim Revision 2 of Regulatory Guide 4.15 and other related
publicly available documents, including public comments received, can
also be viewed electronically on computers in the NRC's Public Document
Room (PDR), which is located at 11555 Rockville Pike, Rockville,
Maryland. The PDR's reproduction contractor will make copies of
documents for a fee. The PDR's mailing address is USNRC PDR,
[[Page 15175]]
Washington, DC 20555-0001. The PDR can also be reached by telephone at
(301) 415-4737 or (800) 397-4205, by fax at (301) 415-3548, and by e-
mail to [email protected].
Please note that the NRC does not intend to distribute printed
copies of Interim Revision 2 of Regulatory Guide 4.15, unless
specifically requested on an individual basis with adequate
justification. Such requests for single copies of draft or final guides
(which may be reproduced) should be made in writing to the U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, Attention:
Reproduction and Distribution Services Section; by e-mail to
[email protected]; or by fax to (301) 415-2289. Telephone requests
cannot be accommodated.
Regulatory guides are not copyrighted, and Commission approval is
not required to reproduce them.
(5 U.S.C. 552(a))
Dated at Rockville, Maryland, this 15th day of March 2007.
For the U.S. Nuclear Regulatory Commission.
Brian W. Sheron,
Director, Office of Nuclear Regulatory Research.
[FR Doc. E7-5932 Filed 3-29-07; 8:45 am]
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