Regulatory Guide 10.5: Difference between revisions

From kanterella
Jump to navigation Jump to search
(Created page by program invented by StriderTol)
(Created page by program invented by StriderTol)
Line 1: Line 1:
{{Adams
{{Adams
| number = ML13350A214
| number = ML081140591
| issue date = 09/30/1976
| issue date = 07/01/2008
| title = Guide for the Preparation of Applications for Type a Licenses of Broad Scope for Byproduct Material
| title = (Revision 2), Application for a Type a License of Broad Scope
| author name =  
| author name =  
| author affiliation = NRC/OSD
| author affiliation = NRC/RES
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person =  
| contact person = Orr M/RES/415-6373
| document report number = RG-10.005
| case reference number = DG-0015
| document report number = RG-10.5, Rev 2
| package number = ML081140554
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 8
| page count = 3
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY  
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION
COMMISSION
July 2008 Revision 2REGULATORY GUIDE
September
  OFFICE OF NUCLEAR REGULATORY RESEARCH
1976* REGULATORY
    REGULATORY GUIDE 10.5 (Draft was issued as DG-0015, dated January 2008)
GUIDE OFFICE OF STANDARDS
APPLICATIONS FOR A  TYPE A LICENSE OF BROAD SCOPE
DEVELOPMENT
REGULATORY  
GUIDE 10.5 GUIDE FOR THE PREPARATION
OF APPLICATIONS
FOR TYPE A LICENSES OF BROAD SCOPE FOR BYPRODUCT
MATERIAL


===1. INTRODUCTION ===
==A. INTRODUCTION==
1.3 Items Requiring Separate Applicamtions
This guide directs the reader to the type of information needed by the U.S. Nuclear Regulatory Commission (NRC) staff to evaluate an application for a Type A license of broad scope for byproduct material. Title 10,  Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," of the Code of Federal Regulations (10 CFR Part 33) (Ref. 1) regulates this type of license.
1.1 Purpose of Guide a. Gamma Irradiatiun iaciliticvs,%-
A\ separate appqlicati,.n bb`uld he .,,tdllilled  This guide describes
[he type and extent of iiifornia- sAl seourac aplicatio.natdl he chiied oi'lion needed by the NRC staff to evaluate an application scald sourrcs tia wnact IOU curkls for for a Type A specific license of broad scope for gamma irradiaton'
7 aspell&Uns is availnbg upn byproduct material (reactor-produced radionuclides).
request. ,; .This type of license is provided for under Title 10, Code of Federal Regulations.


Part 33. "Specific Licenses of b. Products ibted to4the Public Broad Scope for Byproduct Material." A bt 1  i does atithotii, the TheType A specific license of broad scope is intended distributiot piblic of iroducts ,adio-to accommodate those institutions involved in an exten. nucI'quest the Raduisutopes Licensing, sive radioactive material program where the demand is -Wan ti ul Fuel Cycle :nd Materi:l Satctv.great for a variety of radionuclides for many uses. Thii tz~inuclear Material Safety and Safegzuards.
This regulatory guide endorses the methods and procedures contained in the current revision of NUREG-1556, Volume 11, "Consolidated Guidance about Materials Licenses:  Program-Specific Guidance about Licenses of Broad Scope" (Ref. 2), as a process that the NRC staff finds acceptable for meeting the regulatory requirements of 10 CFR Part 33.


will type of license is tile most comprehensive" issued an%.. u'It' the type of ilttormitatiori that the a;plicant may be written to cover a wide range of radiunuclid&.
Volume 11 of NUREG-1556 is not intended to be used alone. Because broad-scope licensees may be involved in many different program areas (e.g., medicine, research and development, manufacturing and distribution), Volume 11 frequently refers the user to other more program-specific guidance documents in the NUREG-1556 series.  A single document containing all of the guidance that might be required by a broad-scope licensee or an applicant for a broad-scope license would be unwieldy and may become obsolete as guidance in the individual program areas is revised.  Volume 11 of NUREG-1556 takes a more risk-informed, performance-based approach to the information needed to support an application for a specific license of broad scope.  Applicants should consider the entire NUREG-1556 series when preparing broad-scope license applications.  NRC staff will use applicable portions of the complete NUREG-1556 series when reviewing applications.
Z, Ig"ul 1 itubiit in support ot0 such alt applica'iii.(e.g., all radionuclides with atomic numbers I th 9ugJt '4' Source and Special Nuclear Materials 83) for use under the control of a radiatiu committee.


The license may authorize an use " Separate applicatiOns shlould be suhi,,itted for byproduct radioactive material by anyon* a these materials in accordance with Part 40. "Liiccusime Of with review and approval procedures
The NRC issues regulatory guides to describe and make available to the public methods that the NRC staff considers acceptable for use in 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 reviewing applications for permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.
..le Source and Part 70. "Special NutcleJ i Mte-radiation safety committee.


Therefom kindivi als are rial'" of 1O CFR. Source ma Jclrial is ill ptagrla)h not namted on the license as users of ra .,aterial
This guide was issued after consideration of comments received from the public.
4U.4(h) of 10 Ci:R Part 40 3s ( I) uranium orit ir imhll, nor are radionuclides limited to narrow. ciric uses. or any conibination theretit', isl ajny phvyic:rl to chlemical This type of license is intended for use by licensees that Iforml (or (2) ores that containl hy weight 1/20 of tire cannot operate under e limited specific license percent (0.05" ) or itlore odl(a) turaiiuilll.


(1h) th10rium1.
Regulatory guides are issued in 10 broad divisions C1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Hea lth; 9, Antitrust and Financial Review; and 10, General.


or Without seriously inc 1.1 their progrtamlls. (c) any cumbinalion Ihlertel'..  
Electronic copies of this guide and other recently issued guides are available through the NRC's public Web site under the Regulatory Guides document collection of the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML081140591.
Source material doe,, nort withou siously inc ni therinclude special nuclear material.1.2 Aplicale tiSpiecial ntuclear material is defined in liarapsaph In addition o 10 R Part 3


===3. other regulations ===
Rev. 2 of RG 10.5, Page 2 This regulatory guide contains information collection requirements covered by 10 CFR Part 33 and NRC Form 313 that the Office of Management and Budget (OMB) approved under OMB control numbers 3150-0015 and 3150-0120, respectively. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.
70.4(ni) of 10 CFR Part 70 as (I) plu Iniium. u raniutim pertainintir t f license arc found in 10 CFR 233. uranium enriched in tie isotope 233 or ill Ihe Part 19 ! s, ructions.


and Reports to Workers: isotope 235. and any other material that ihc Co(irrrris- lnspectiom
==B. DISCUSSION==
10 CFR Part 20, "Standards for Protection sion pursuant ito the provisions of Section 51 of fie Against Ra n:" 10 CFR Part 30. "Rules of General Attmic FInergy Act utif 1954, as amended. delerriiiics itt Applicability to Licensing of Byproduct Material:" and be special nuclear material hut dtles 11o1 iclitde soiricc 10 CFR Part 170, "Fees for Facilities and Materials material or (2) any material artificially enriched hy any Licenses Under the Atomic Energy Act of 1954. as orie of the foregoing but ducs ritn include source Amended." ma ItCria
As part of its redesign of the materials licensing program, the NRC consolidated and updated numerous guidance documents for material licenses into the multivolume NUREG-1556. Various volumes in the NUREG-1556 series provide current, program-specific guidance on testing, licensing, decommissioning, and terminating materials licenses.


====l. USNRC REGULATORY ====
Volume 11 of NUREG-1556 identifies information needed to complete NRC Form 313, "Application for Materials License," for broad-scope licenses. It contains appendices that include (1) copies of necessary forms, (2) sample applications and completed examples for different types of applications, and (3) examples of the types of supporting information, such as implementing procedures, that the applicant may need to prepare. The NRC is placing added emphasis on conducting its regulatory activities in a risk-informed and performance-based manner. This approach is intended to be less prescriptive and to allow licensees the flexibility to implement the agency's regulations in a manner that is more specific to their needs yet still meets the regulatory requirements. By supplying examples, the NRC seeks to provide information to meet the needs of applicants for licensure without being prescriptive. Guidance in NUREG-1556 represents one means of complying with NRC regulations and is not intended to be the only means of satisfying the regulatory requirements.
GUIDES Commnents s~hould te sent to the Secretary ot the Con,,n,..wr U SNuflty., Reglatry -ds A* %.*dtodowbirandmae dtedbletothepubic Rliul~ltoey Commissioan Wacth-ngton.


DC MW~.5 Alterma~n Duchot,,.  
==C. REGULATORY POSITION==
and mnethods acceptable to the NIIC *fttall of iplemtenting specific pa's, of the ewScto Conmmit, on I eegcetatlo..e, to doeh,,eato techn~qvet used by the %fell in evalu the g..od*% ar. .%sued .. the tolt,,*.ng ton broad divisions Atn4 , sicifoc oroblerat Or poitfulAtod Accidents.
This regulatory guide endorses the method for preparation of a Type A license of broad scope for byproduct material described in the current revision of NUREG-1556, Volume 11, as a process that the NRC has found to be acceptable.


at to povaide guidance to appl#c ants Regultiory C-das DC not sub~tltutey to, *egtalions,.
==D. IMPLEMENTATION==
And com'pliance I Poe... R.., tots 6 Products.,dhth a.t nsot #ifeqioed Malthadi and solut,GPI.
The purpose of this section is to provide information to applicants and licensees regarding the NRC's plans for using this regulatory guide. The NRC does not intend or approve any imposition or backfit in connection with its issuance.


.1-tle,*at lyo-, those set "It in 2 Ste%*a,ch arnd Test Reacqa-y I ~np~it, this guideeillt be acceptable.
In some cases, applicants or licensees may propose or use a previously established acceptable alternative method for complying with specified portions of the NRC's regulations. Otherwise, the methods described in this guide will be used in evaluating compliance with the applicable regulations for license applications, license amendment applications, and amendment requests.


of their provide & bag,% toe the finllng% ,eocu.Wot to 3 Nuett and Arat.'at, F a.1i.t.eo a Oct,aptoa Healith this .ctUAnte Of te~ntE'u4"C?
Rev. 2 of RG 10.5, Page 3 REFERENCES
i AI aPe-1 Me~ OF,Can%0 b, the Co-In,pe,t
1. 10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.
4 1nv-ari-entat and Siting 9 Armtlo.1~
tpy Comment% anid *uqqe-t-On*
ti, .ltp,acernewst
-these guide, ae rok,ioAgod
-5 Mate.ats anti Plant pflt'.tet,, 10 Ge,,,.,a At tt tmime,, :-d yu.odet wnil he ,.aited. at appooptsele.


to Accommodate cam Zeat,iad;
1  2. NUREG-1556, Volume 11, "Consolidated Guidance about Materials Licenses:  Program-Specific Guidance about Licenses of Broad Scope," U.S. Nuclear Regulatory Commission, Washington DC, most current date and revision.
to 10 reIe -. ,-n-aMAl~or, ..or ec I tw~e o-mment, o. Cop..cs 0t published guide% m'ay he obtained by, --iont request ind.cat~n9 the tfit & 'do, 04&~..ed ..the. ob.1.t t*O mril'tt allt*# it& issuiance wilt be os- dntwvao dete tl.,U Nuctear faegutatoiry Commission, Washingtonr.


0 C t.Cute'tv uitt ne.taat.rig the need tor i'etn eoa,...Von
2  (http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/)                                                         
1055. Ateton Doirecto,.
1  All NRC regulations listed herein are available electronically through the Electronic Reading Room on the NRC's public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Copies are also available for inspection or copying for a fee from the NRC's Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email PDR@nrc.gov. 2  The multivolume NUREG-series report listed herein was published by the U.S. Nuclear Regulatory Commission. These volumes are available electronically through the Electronic Reading Room on the NRC's public Web site, at http://www.nrc.gov/reading-rm/doc-collections/nuregs/. Copies are also available for inspection or copying for a fee from the NRC's Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email PDR@nrc.gov. In addition, copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328, telephone (202) 512-1800; or from the National Technical Information Service (NTIS), at 5285 Port Royal Road, Springfield, VA 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.}}
Office of Standard, Dsi,ototniont
1.4 As Low As Is Reasonably Achievable (ALARA)Paragraph
20.1(c) of 10 CFR states the "...persons engaged in activities under licenses issued by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganiza- tion Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effort to maintain radiation exposures, and releases of radioactive materials in effluents to tun-restricted areas, as low as is reasonably achievable." Regulatory Guide 8.10, "Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable," provides the NRC staff position on this important subject. License applicants should give consideration to the ALARA philosophy, as described in Regulatory Guide 8.10, in the development of plans for work with licensed radioactive materials.
 
Z LICENSE FEES An application fee is required for most types of licenses.
 
The applicant should refer to § 170.31,"Schedule of Fees for Materials Licenses," of 10 CFR Part 170 to determine the amount of the fee that must accompany the application.
 
Review of the application will not begin until the proper fee is received by the NRC.3. FILING AN APPLICATION
A license application for Type A licenses of broad scope should be submitted on Form NRC.313,* "Appli-cation for Byproduct Material License" (see the ap-pendix to this guide). All items on the application form should be comp:cted in sufficient detail for the NRC staff to determine that the applicant's equipment, facilities, and radiation protection program are adequate to protect health and minimize danger to life and property.Since the space provided on Form NRC-313 is limited, the applicant should append additional sheLts to provide complete information.
 
Each separate sheet or document submitted with the application should be identified by a heading indicating the appropriate item number (Form NRC-313) and its purpose, e.g.. radiation safety instructions, etc.The application should be completed in triplicate.
 
The original and one copy should be mailed to: Radiuisotopes Licensing Branch, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Comnission, Washington, D.C. 20555. One copy of the application,*Form NRC-313 was formerly designated Form AEC-313.Existing copies or Form AEC-31 3 may still be used.with all attachments, should be retained by. the appli-cant, since the license will require as a condition that the licensee follow the statements and representations set forth in the application
.;nd any supplement to it.4. CONTENTS OF AN APPLICATION
Most items of Form NRC.313 are self-explanatory (see instrucions with the forn). The following com-ments apply to the indicated items of (lie form.Itcen 4. State that radioactive materials are to be used by individuals designated by the radiation safety committee, and state the name of the chairman of the committee.
 
Item 6(a). The usual entry is: "Any byproduct material with atonic numbers I through 83." If alpha.particle emitters are to be excluded, it should be so stated. If radionuclides with atomic numbers above 83 are include-d, they should be specifically identified.**
Item 6(b). Possession limits should be stated. A possession limit is that quantity of" radioactive material that a licensee nmay have in his possession at any one time. For example, a total of one curie with a limit of 10 millicuries for each radionuclide between atomic num-bers I and 83, inclusive, may be adequate.
 
If the applicant requires higher possession limits for certain radiunuclides, such needs should be clearly stated. It may also be necessary to limit the quantity of more hazardous radionuclides such as strontium
90. The possession limits for radionuclides with atomic numbers above 83 should be stated separately from those requested for atomic numbers I through 83. The total possession limit (i.e., the total quantity of all radio.nuclides that the applicant desires to possess at any one time) should include those radionuclides with atomic numbers above 83. The requested possession limit should be commensurate with the applicant's needs and facilities for safe handling.
 
Stored wastes should be included in vstablishing both individual and total posses.sion limits.Item 7. Describe the type and extent of use of radioactive materials at each address given in Item l(b).Such descriptions may be given in general terms but should characterize each use*** to the extent necessary for a determination by the NRC staff of the suitability of"Source or special nuclear material should not be Included.Separate applications should be submitted for these materials in accordance with 10 CFR Parts 40 and 70.*"*A broad specific license does not authorize the use of radlonuclides in the field whete release of tadioactive material to the environment is involved.
 
Approval of requests for such uses is dependent upon supporting Information specific to such uses. Upon request, the Radioisotopes Licensing Branch, Division or Fuel Cycle and Material Safety, Office of'Nuclear Material Sarety and Safeguards.
 
will describe the type of information necessary for an applicant proposing such uses.10.5-2 the equipment, facilities, and personnel training and experience.
 
lictis 8 and 9. In addition to the information requested in Item 14 and specified below, the criteria and procedures for training and detcrmining an accept.able level of knowledge of all persons who will work in or frequent a restricted area (i.e., users of radionuclides, technicians, health and safety personnel, janitorial work-ers, etc.) should be described (refer to § 19.12 of 10 CFR Part 19). The maintenance of records of all training, testing, and competency determinations should be specified in the application.
 
Item 10. List the minimum number of radiation surveying, monitoring, and measuring instruments that the applicant will have available for the safe use of radioactive material in accordance with Commission regulations.
 
The applicant should specify the type of instruments that will be made available to individual users.Instruments should be listed by characteristics (i.e., detector type, radiation detected, detection range, win.dow thickness, etc.) and intended use (i.e., measuring, surveying, monitoring, etc.).Item 11. Describe the instrument calibration pro.cedure. State the frequency, and describe the methods and procedures for calibration of survey and monitoring instruments, as well as any other instruments and systems used In the radiation protection program, such as measuring instruments used to assay sealed.source leak-test samples, contamination samples (e.g., air sam-pies, surface "wipe" samples), and bioassay samples (see Item 12).An adequate calibration of survey instruments usually cannot be performed with built.in check sources.Electronic calibrations that do not involve a source of radiation are also not adequate to determine the proper functioning and response of all components of an instrument.
 
Daily or other frequent checks of survey instruments should be supplemented every 6 months with a two.point calibration on each scale of each instrument with the two points separated by at least 50% of the scale.Survey instruments should also be calibrated after repair.A survey instrument may be considered properly calibrated at one point when the exposure rate measured by the Instrument differs from the true exposure rate by less than 10% of full scale.If the applicant is contracting out the calibration or instruments, the name, address, and license number of the calibrating firm should be given along with the frequency of calibration for each type of instrument.
 
1It,: 12. Describe fully the personnel monitoring program, including the types of monitoring devices to he used, the criteria to be used in determining the need for each type or device. the name of the organization furnishing Film badge or thermoluminescent dosimeter (TLD) service, and the frequency for changing badges.rings, etc. If pocket chambers or pocket dosimeters arc used, state the useful range, frequency of reading. and the procedures for maintaining and calibrating the devices.The applicant should show that the need for bio-assays has been thoroughly considered and should establish the adequacy of the proposed bioassay pro-gram in relation to the proposed program of use of radioactive material.
 
Bioassays are normally requited when individuals work with millicurie quantities of hydrogen 3, iodine 1 25, or iodine 1 31 depending on the type of work. equipment, and procedures followed.Other materials may also be used in physic:. or chemical forms and under conditions that present an opportunity for uptake by the body through ingestion, inhalation, or absorption.
 
A bioassay program to determine and control the uptake of radioactive material should be considered and discussed in relation to each such material, procedure, etc.The criteria to be used in determining the need for bioassays, the type and frequency of bioassays that will be performed, and the bioassay procedures should be specified and described in detail. If a commercial bioassay service is to be used, the name and address of the firm should be provided.Bioassavs may not be substituted for other elements of a safety program such as air monitoring and disper.sion control (hoods, glove boxes. etc.) and (or well.thought-out and well-executed handling procedures.
 
Item 13. A general description should be providcd of facilities and equipment (e.g., buildings, hood ventilation and filtering systems, general air and stack monitoring systems, remote handling equipment)
and access control methods used in association with the handling and storage of byproduct material.Minimum facilities should be described, and an explanatory sketch should be included of each area (i.e..site, building, laboratory, room) where especially haizard-ous materials are used and stored or where especially hazardous operations are performed.
 
Radionuclides to be used in specific areas may be identified by their characteristics (i.e., beta emitter.gamma emitter, etc.) in lieu of specific atomic and mass numbers.NOTE: Information submitted in support of a license application will become part of any license that is issued.This means that the licensee may be required to obtain a 10.5-3 license amendment prior to making changes to his facilities or equipment.
 
Item 14. All components of the application that contribute to the radiation protection program should be discussed in a narrative that establishes their relation-ships, interfaces, and contributions to the overall radi-ation safety program. The relationships of the radiation safety committee, the radiological safety officer, and management should be included.
 
An o:ganizational chart or charts may be helpful In this regard.The application should demonstrate that the appli-cant can comply with license requirements and NRC rules and regulationts and should clearly show an active and continuing involvement in program control by management.
 
a. Radiation Safety Committee Paragraph
33.1 3(c) (1) of 10 CFR Part 33 requires that a radiation safety committce be established.
 
This commitlee should be composed of such p-rsons as a radiological safety officer, a representative of manage-ment. and other persons trained and experienced in the safe use of radioactive materials.
 
One of the main functions of the radiation safety committee is to administer the institution's radioactive material program.The committee should have the authority and responsi-bility for approval and disapproval of all proposals for radionuclide use prior to purchase of the materials.
 
The following information concerning the commit-tee should be submitted:
(1) A list of members of the committee.
 
(2) A description of each member's training and experience with radiation and radioactive material.(3) A specific and detailed description of the control functions of the committee and tile administra- live procedures by which these functions are carried out, including the following: (a) Responsibilities, duties, and authority of the committee.(b) Frequency at which the full committee (or quorum) meets to discuss and act on proposals for the use of radionuclides.
 
If less than the full committee is empowered to act for the committee, the number of members constituting a quorum, as well as their names or fields of expertise, should be specified.(c) Procedures and criteria established for mak-ing safety evaluations of proposed uses of radioactive material.
 
The procedures and criteria should include consideration of the adequacy of facilities and equip-ment; operating, handling, and emergency procedures;
and tile experience and training of the proposed users of the material.(d) Procedures used for controlling and main-taining inventories, procurement of radioactive material, individual possession limits, total possession limit, trans-fer of radioactive material within the institution, and transfer of radioactive material to persons outside the institution.(e) Methods employed for maintaining records of tihe committees proccedings and safety evaluations of proposed uses of radioactive material.(f) Periodic review of the safety program, including review of records required to be maintained.
 
b. Radiological Safety Officer*Paragraph
33.1 3(c) (2) of 10 CFR Part 33 requires that a radiological safety officer be appointed.
 
The radiological safety officer should be responsible for overall radiation protection within the institution.
 
A description of his training and experience in radiation protection and with radiation and radioactive material should be provided.
 
A statement should be included delineating his duties, responsibilities, and authority for carrying out the radiation safety program. The extent of his responsibility and authority will depend on the scope of the proposed program; however, the following should be considered:
(1) General surveillance over all activities involv-ing radioactive material, including routine monitoring and special surveys of all areas in which radioactive material is used.(2) Determining compliance with rules and regula-tions, license conditions, and the conditions of project approval specified by the radiation safety committee.
 
(3) Monitoring and maintaining absolute and other special filter systems associated with the use, storagec or disposal of radioactive material.(4) Furnishing consulting services on all aspects of radiation protection to personnel at all levels of respons.ibility.(5) Receiving, delivering, and opening all ship-ments of radioactive material arriving at the institution and receiving, packaging, and shipping all radioactive material leaving the institution.
 
Thie terms "radiologist afety officer" and "radiation protec.tion offim.:" are synonymous Ii 10.5.4
(6) Distributing and processing personnel mioni.toring equipment.
 
dctermining die need for and evalua.I tion of bivassays:
keeping personnel c 1IWsuWe and bioassay records; and notifying individuals and dicir supervisors of exposures approaching niaximniu perntis-sibic amounts ane recommending appropriale remedial action.(7) Conducting trainiing programs and otherwise instructing personMel in the proper procedures for the use of radioactive material p[rior t) use. at periodic intervals (rtfrcshej training), and as required by changes in procedures, equipment, regulations.
 
etc.(8) Supervising and coordinm'ing the radioactive waste disposal program, including keening waste storage and disposal records and mtonitoring effluents.
 
(9) Storing all radioactive materials not in current use, including wastes.(10) Performing leak tests on all scaled sources.(I I) Maintaining an inventory of all radioisotopes at the institution and limiting the quantity of radio-nuclides at the institution to the amounts authorized by the license.(12) The authority to terminate immediately a project that is found to be a threat to health or property.(13) Maintaining other records not specifically designated above, eg., receipt, transfer, and survey records as required by §30.51 of IOCFR Part 30.c. Radiation Protection Procedures A formal set of rules, instructions, and procedures for procurement, disposal, and safe handling of radio-nucildes within the institution should be established by the radiation safety committee.
 
A copy of these rules and procedures in the form in which they will be given to all personnel under the jurisdiction of the committee should be submitted.*
Where instructions are given with respect to an action necessary for compliance with NRC regulations (e.g., waste disposal), such instructions should be specific and not consist of a simple reference to the regulations.
 
The written radiation protection procedures should be clear and concise and should cover the following:
*Although a specific set of rules and procedures Is desired as a basis for evaluating the license application, the applicant may specify that certain portions of the documents may be revised without prior notification of the NRC staff. Those sections containing specific dates. references to particular pieces of* equipment, etc., may be considered in this category.(I) Process fur obtaining ipermission it) to,, radio.active materials at the inritutinito.
 
(2) Care, selection, and use of protective upparel and other equipment and facilities.**
(3) Limitalimns and conditions (special equip-ment, facilities, and procedures)
relative to haiidlirg,- liquid, gaseous, finely divided or tncontaimcd tadio.wtivc materials*
and the equipment to use in working witi them. For example. the types of materials and opera-tions that should be confined to ventilated equipmentnt with filte r.d exhaust systems (e.g.. radiochemical fltine hoods or glove boxes) and the types and amounts of shielding and re"-.., li:bndling equipment to be used with hard beta- a,n dj,, eamnta-emitting materials shotld be defined.(4) Special e.,uip-nent, procedutes. -nd ptecau.tions to be used in %,.orking with neutron and lplia-particle etiitiers and radionuclides that decay by spontaneous fission.(5) Surveying and monitoring procedures a. be followed during day.to-day operations.
 
(6) Emergency procedures and instructions con-cerning spills, fires, release or loss of material, and accidental contarnination of personnel.
 
including decon-lamination procedures and those persons to he notified in an emergency.
 
(7) Posting and control of access to restricted areas, radiation areas, 'high radiation areas. etc. (see§20.203 of 'OCFR.Part
20).(8) Requirements for material storage and safe.guarding:
labeling containers:
processing and storing con-taminated articles, including
6gassware:
and identifying areas where radioactive material is used and stored (see§20.203 of 10 CFR Part 20).**A complete description of respirator), protectivn devi's and procedures for fitting, sanitizing, and repairing should be included.
 
Credit for respiratory protection cannot bXe taken unless approved by the Commission pursuant to §20.10.3 of 10 CFR Part 20.*nThosc applications or operations that present unusual hazards because of the nature or the material, the quantity involved, and the type of operation and that may require specialized facilities should be covered in separate instruc-tions rather than incorporating these instructions in the main body or the radiation protection procedures.
 
I 10.5-5
(9) Care and use of personnel monitoring devices, where to obtain them, and where and when to record exposure results.(10) Requirements for bio3ssays, if any, and the procedures for providing bioassay samples.(11) Transporting radioactive material between buildings and rooms.(12) Acceptable and unacceptable levels of con-tandnation (fixed and removable)
for equipment, facili-ties, clothing, skin, etc., in both restricted and un-restricted areas and protective action (i.e., decontamina- tion, disposal.
 
etc.) to be taken with respect to unacceptable levels.(13) Requirements and procedures for leak-testing sealed sources.(14) Requirements and procedures for waste dis-posal, inluding limitations on disposal of liquid, gaseous, and solid wastes. If radionuclides will be administered to animals, instructions for cleaning animal quarters and handling animal excreta and carcasses should be included.(IS) Requirements and procedures for the development and maintenance of records with respect to the receipt, use, and disposal of radioactive material.(16) Requirements and procedures for picking up, receiving, and or-cning packages (see § 20.205 of 10 CFR Part 20).Item 15. A specific method for disposing of by.product material waste should be described.
 
A licensee may dispose of waste in the following ways: a. Transfer to a person properly licensed to receive such waste.b. Release into a sanitary sewer in conformance with§20.303 of 10CFR Part 20.c. Burial in soil in conformance with §20.304 of 10 CFR Part 20.d. Release into the air or water in conformance with§20.106 of 1OCFR Part 20.e. Treatment or disposal by incineration In confor-mance with §20.305 of 10 CFR Part 20.f. Other methods specifically approved by the NRC pursuant to §20.302 of 10 CFR Part 20.
 
===5. AMENDMENTS ===
TO A LICENSE Licensees are required to conduct dheir programs in accordance with statements, representations, and pro-cedures contained in the license applicatlun and sup-portive documents.
 
The license must therefore be amended if the licensee plans to make any changes in facilities, equipment (including monitoring and survey instruments), procedures, personnel, or byproduct material to be used.Applications for license amendments may be filed either on the application form or in letter form. The application should identify the license by number and should clearly describe the exact nature of the changes, additions, or deletions.
 
References to previousiy submit-ted information and documents should be clear and specific and should identify the pertinent information by date. page, and paragraph.
 
6. RENEWAL OF A LICENSE An application for renewal of a license should be filed at least 30 days prior to the expiration date. This will ensure that the license does not expire until final action on the application has been taken by the NRC staff as provided for in paragraph
30.37(b) of 10 CFR Part 30.Renewal applications should be filed on Form NRC-313, appropriately supplemented, and should con.tain complete and up-to-date information about the applicant's current program.In order to facilitate the review process, the applica-tion for renewal should be submitted without reference to previously submitted documents and information.
 
If such references cannot be avoided, they should be clear and specific and should identify the pertinent informa.tion by date, page, and paragraph.
 
10.5-6 APPENDIX*1 farm~ A(C-3l53 42.131 11) CFi I0 UN"ID AtOPA INCI"416 COMM/5lOr,0
APPLICATION
FOR BYPRODUCT
MATERIAL LICENSE 11r "ft-gNST$RUCTIONS -Conigtl.l fierm I lrh'ovh l6 dl Ihs .% a,*'a Appsl-cal-oE
Or 4, Ittt"Call.of to, wow~@s, of a hCOM1a Wo-Ml0,¶A
caml C0¶fltd m v '-VIoll aptplcallons filed *-th thitComm~uwom wah respect to ftems 6 tlhot.gft IS may bre -i'itwo'soled b, reference pl'0.ded tefffemces A'S Cfs~f and sapOcitic Ue supplarmeftal shoots whereE necessary nerm tb mull be cc-pletled on all Appi-CUl-ont
&#&. t.0 too-as 10 U S AloC-c Energy 0romra,t-soon. WasI¶hm~lof.
 
0 C .20$45 Aflonl,oni Ue#1t~ras stanch D,'erloral#
of Lwloflliq Upon applo.81o h q 01.So*pihti.of.
 
Ohs SAVI,tiam inm-u~~ an AEC Byproduct Materral Li~qnso An AEC l,v'odwct
1641wr,81 L~corse -s issued .n occordamcs .Ili th~e g
 
====r. a ornel Contarled ====
.' Life 10, Cod* of Fad.*SIC Rotgualtins.
 
Pall 30 Old the Licence. -S lu"tdl 10 Tun '0 Code of Fedwa1 RegulAhorr Pall 20 $Ad the I-cetw to* pro.I-a-s
0; T~tke 10 Codf of Fedsirst Reguelations, Part 110 Thet 1cors ta feaeteottfi ShOW14 be Stated let Item T6 anid me gooarophto too encltioda
(546 Note 'n lerst'.,ctuof SP-eels I lei P~lt Alit)STRIEV
LOA0011SOO0
APOLtCANI
ji l..ro, t.-. "toils' pe b. S111111 taS$LS At -..C. .,C~~I ..II , .t $1*C1 sofl Stei..fP o.Cd,~Ar..m.
 
d.'.e. '.1ýI- l. 1.4I. 10 C %2 01?Altffltt4 It) QU1 *vf#O0V1 .Aft&IAI I 0PEIAIOUS
liCINS1 t.(JAleis1
('' 0'i0' *m0i w00W -4.%~o 0d 9 -. -Ce 1 4 INDIVIDUAl U31#131tM.
 
No.. 0,.4 frI e -he.,, A..I ..#i or* dw.), 5 NAIapATtOf
0*o07WPO,.
0111CIN lNo-t.05 P.-~~ -~.'oof. .a bippid.0 ao'w' G..# rto'a-9 -4 O*.P.-O I. 11 0-d 9 OrW J5 ws.. fmr ..d... .£9. -.,-.o o A-$ 1-0-9 rfd -ow-o.6 tei dIPIOoucf u"llsimA tl6-04 tbi 0CNEMICAL
AP40,OC PH111ICAL
001" Ap40 MAI-vwl HIJA4IS Of MItCURIIl Of I -C. Cn.1-CAt AND )A 04 trrr end i1 ..0b" of l'ot I OCLtI 9015 VHAt IOU WtL~ P0$54$$ At AV Ot.1 ISfi 91ooil 4 i0 5-'...,..-t.~-.
of -11.'- Goo .0l' i.1, ofl~ 04"... If b~pu.4. I-'.W ft -o .0 t... ..ebd ... -',.U 0. ~Iw* -~d 1Oe 00.4 11-r .0.9 al" --oe-04- do... I0. o ~v.-asfed o.e .-.d)(Confiftwed ileanamiet Glde 10.5-7 APPENDI X- (Continued)
TRAINING AND EXP~QENCi OF EACH INDIVIDUAL
NAM!OD IN ITEM * , ve.o 1'..'a P,,Xoo.s o~d 0533et 03 *of~'o- * ~#-~a-1 fl- 40.cla.e o-d Yet 0 4.yet. No d 9S0019-tat
4044 of 100.0-o 0- Too No Vol No 9 tlft[VINCE
WIT" OOOIATIO A.0'3.e 'ode00. *o' ~~p.. a,3 t1t9 A1303~j A-1Ef 'tI~j..C4 vAA ',A'-4 .OLJIAV'C.
 
O 10' lNItNCI Ie f0-10 ___ -AITO -VCT0 .f ''PlO' oilV r~O IAI~of 0tT~oC70N
siUCY Numi~ove 0 I *'Al' SISTII 4Atf1WNO KC011 l If.'ft--1 we I MIl -to .1 A-l 4j Of a 'It M111,100,011OUINC1.
 
A40j SltAhIA1f0
SIbINt 3* Al.IC JIN$III OV 1) Ilk" %&Doti o0sW711t1.
 
AftD %to ASSAY flotfoLIIs USID AL- btdi. W e~. N .dý *I to, "".9 a-1 P03te'l0 0 o.0 eof 4ol )wIe INFORMATION
TO Of SUSDAITTID
ON ADDITIONAL
SHEETS IN DUPLICATE
_____13 FAMMi~IS AND IOIAPM1NI
b.t,',t .t.Ww *S4 s'O 't.%so 9,4 10*kaodi..
f~pa*cow 309 "isq,.t)gi.'.~pj
~~,N.6,-9~ 0*o4.d.'..
pp- "I' 0. .9-'c.9' 4-. d~,' 0.400.,0140c of o.ws. to psolIo '... loo 8- ....g-., t' IW .-f --0. --, od....*..15 WVASIi 0'I0AI 14 0 to-o*'-41
-.-*N d*ooI e--~(o 'I sVatokpd.
 
*P'Ipms ~ of* *to~po on," %ý- 6410-10d O.om.pl-owt of ..%dfto.t_*4
,.41~ ~ £P~IC~ AN~ ANYCltRTIFI5AT
(1hts Itsoemust'
be tatpinete-d byaRRI-ItaM)__________
10 ,mfA1111CNI
ND NY PIIt~lIXICUIING
tHIS CI tI'ICAtt 0N Sit ALF 0? toot A*Y1?CANT
MAJID IN ITjM mI. CIA1IFY THA TS APFUCAVION
It pvtoaltt oIN cow. otlv Wit mi t i o. coot at Ptol8At SGUtATIONS.
 
Io4* 30. AtD 0THAT Att IN) OIATION CONAINIC M11111M. INCIVOI04G
ANy SUMfIMINtS
ArTACHID 4111TO. IS MgU AND COPSIC 10 104( Ulf of OUt IF40W~lDCI
AND U1111 LWA-10.. fee. Colog" fee tmoeolod s By;WAINWOM.-I
U. S. C.. 11ei,.oi 1001, Ato of J.As 23. 1941; 62 $wa. 749. -54lff 9 0 a c.kite0I O seM. I& make 6 w'l1T~VIpIsl
16 016t,6If I o~ 0#*~m tw toty d.eatts~mo at .o' Ito Uot-td States at 40 a-Vlsy o C4 ,I% ti 5w I*.14'Ittooft.
 
* U.S. 00G I'2StIIII 10.5-9}}


{{RG-Nav}}
{{RG-Nav}}

Revision as of 04:08, 30 August 2018

(Revision 2), Application for a Type a License of Broad Scope
ML081140591
Person / Time
Issue date: 07/01/2008
From:
Office of Nuclear Regulatory Research
To:
Orr M/RES/415-6373
Shared Package
ML081140554 List:
References
DG-0015 RG-10.5, Rev 2
Download: ML081140591 (3)
v • d • e


U.S. NUCLEAR REGULATORY COMMISSION

July 2008 Revision 2REGULATORY GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 10.5 (Draft was issued as DG-0015, dated January 2008)

APPLICATIONS FOR A TYPE A LICENSE OF BROAD SCOPE

A. INTRODUCTION

This guide directs the reader to the type of information needed by the U.S. Nuclear Regulatory Commission (NRC) staff to evaluate an application for a Type A license of broad scope for byproduct material. Title 10, Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," of the Code of Federal Regulations (10 CFR Part 33) (Ref. 1) regulates this type of license.

This regulatory guide endorses the methods and procedures contained in the current revision of NUREG-1556, Volume 11, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses of Broad Scope" (Ref. 2), as a process that the NRC staff finds acceptable for meeting the regulatory requirements of 10 CFR Part 33.

Volume 11 of NUREG-1556 is not intended to be used alone. Because broad-scope licensees may be involved in many different program areas (e.g., medicine, research and development, manufacturing and distribution), Volume 11 frequently refers the user to other more program-specific guidance documents in the NUREG-1556 series. A single document containing all of the guidance that might be required by a broad-scope licensee or an applicant for a broad-scope license would be unwieldy and may become obsolete as guidance in the individual program areas is revised. Volume 11 of NUREG-1556 takes a more risk-informed, performance-based approach to the information needed to support an application for a specific license of broad scope. Applicants should consider the entire NUREG-1556 series when preparing broad-scope license applications. NRC staff will use applicable portions of the complete NUREG-1556 series when reviewing applications.

The NRC issues regulatory guides to describe and make available to the public methods that the NRC staff considers acceptable for use in 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 reviewing applications for permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.

This guide was issued after consideration of comments received from the public.

Regulatory guides are issued in 10 broad divisions C1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Hea lth; 9, Antitrust and Financial Review; and 10, General.

Electronic copies of this guide and other recently issued guides are available through the NRC's public Web site under the Regulatory Guides document collection of the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML081140591.

Rev. 2 of RG 10.5, Page 2 This regulatory guide contains information collection requirements covered by 10 CFR Part 33 and NRC Form 313 that the Office of Management and Budget (OMB) approved under OMB control numbers 3150-0015 and 3150-0120, respectively. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.

B. DISCUSSION

As part of its redesign of the materials licensing program, the NRC consolidated and updated numerous guidance documents for material licenses into the multivolume NUREG-1556. Various volumes in the NUREG-1556 series provide current, program-specific guidance on testing, licensing, decommissioning, and terminating materials licenses.

Volume 11 of NUREG-1556 identifies information needed to complete NRC Form 313, "Application for Materials License," for broad-scope licenses. It contains appendices that include (1) copies of necessary forms, (2) sample applications and completed examples for different types of applications, and (3) examples of the types of supporting information, such as implementing procedures, that the applicant may need to prepare. The NRC is placing added emphasis on conducting its regulatory activities in a risk-informed and performance-based manner. This approach is intended to be less prescriptive and to allow licensees the flexibility to implement the agency's regulations in a manner that is more specific to their needs yet still meets the regulatory requirements. By supplying examples, the NRC seeks to provide information to meet the needs of applicants for licensure without being prescriptive. Guidance in NUREG-1556 represents one means of complying with NRC regulations and is not intended to be the only means of satisfying the regulatory requirements.

C. REGULATORY POSITION

This regulatory guide endorses the method for preparation of a Type A license of broad scope for byproduct material described in the current revision of NUREG-1556, Volume 11, as a process that the NRC has found to be acceptable.

D. IMPLEMENTATION

The purpose of this section is to provide information to applicants and licensees regarding the NRC's plans for using this regulatory guide. The NRC does not intend or approve any imposition or backfit in connection with its issuance.

In some cases, applicants or licensees may propose or use a previously established acceptable alternative method for complying with specified portions of the NRC's regulations. Otherwise, the methods described in this guide will be used in evaluating compliance with the applicable regulations for license applications, license amendment applications, and amendment requests.

Rev. 2 of RG 10.5, Page 3 REFERENCES

1. 10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.

1 2. NUREG-1556, Volume 11, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses of Broad Scope," U.S. Nuclear Regulatory Commission, Washington DC, most current date and revision.

2 (http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/)

1 All NRC regulations listed herein are available electronically through the Electronic Reading Room on the NRC's public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Copies are also available for inspection or copying for a fee from the NRC's Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email PDR@nrc.gov. 2 The multivolume NUREG-series report listed herein was published by the U.S. Nuclear Regulatory Commission. These volumes are available electronically through the Electronic Reading Room on the NRC's public Web site, at http://www.nrc.gov/reading-rm/doc-collections/nuregs/. Copies are also available for inspection or copying for a fee from the NRC's Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email PDR@nrc.gov. In addition, copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328, telephone (202) 512-1800; or from the National Technical Information Service (NTIS), at 5285 Port Royal Road, Springfield, VA 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.


Retrieved from "https://kanterella.com/w/index.php?title=Regulatory_Guide_10.5&oldid=1002236"