Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Nuclear Regulatory Commission

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”                            ( print 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).                 

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:                     *NRCREP@nrc.gov.*                     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                     *CAG@nrc.gov.*

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                     *GEP@nrc.gov.*

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,                           ( print 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                     *PDR@nrc.gov.*

                    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                     *DISTRIBUTION@nrc.gov;*                     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.

# Footnotes

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.”
        Back to Citation      

 [FR Doc. E7-5932 Filed 3-29-07; 8:45 am] 

BILLING CODE 7590-01-P