[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,

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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]
BILLING CODE 7590-01-P