ML20135B992

Forwards Info Requested from Sealed Source Safety Section. Draft Calibration Guide Encl

ML20135B992
Person / Time
Issue date:	12/04/1996
From:	Randall K NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Deacon G AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9612060126
Download: ML20135B992 (16)

Text

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i December 4,1996 Mr. Glenn Deacon Quality Assurance Services 1500 Via Hacienda Chula Vista, CA 91913

Dear Mr. Deacon:

Enclosed is the information that you requested from the Sealed Source Safety Section.

If you have any questions or need additional information, please contact me at (301) 415-7857

[

or Steve Baggett at (301) 415-7273.

Sincerely, hl KimBerly Randall, Scaled Source Device Assistant Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

Draft Calibration Guide i

. Distribution:

SBaggett.

l SCDB r/f

NEO2-SSD-1 M DOCUMENT NAME: P: DEACON.WPD Tm receive a copy of t~ is document. Indicate in the tos:

'C' = Copy without attachmentlanclosure

'E" = Copy with attachment / enclosure

• N" = No copy l

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l NAME KR1ndaTI DATE 12/ 9 /96 i

0FFICIAL RECORD COPY E9E512EEUIS COPY oso m

, s 9612060126 961204 PDR RC SSD PDR i

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t-i l-1994' 4

Divisidn.

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~ Steven A.

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Contact:

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(301) 415-7973 l

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U.S. NUCLEAR REGULATORY COMMISSION.

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l OFFICE OF NUCLEAR REGULATORY'RESEARCH'

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i Standard' Review Pla$1 for Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and i

Monitoring Instruments i

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This standard review plan.is for use ith t Re latory,,hde 8

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This regulatory guide is being issued in draft form to involve the public in the early stages of the development of a regulatory position in this area. It has not received complete staff review L.

and does not represent an official NRC staff position.

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Public comments are being solicited on the draft guide (including any implementation schedule) and its associated regulatory analysis or value/ impact statement. Comments should be accompanied by appropriate supporting data. Written comments may be submitted to the Regulatory Publications

' Branch, DFIPS, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC.

20555. Copies of comments received may be examined at the NRC Public Document Room, 2120 L Street NW., Washington DC.

Comments will be most helpful if received by

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i Requests for single copies of draf t guides (which may be reproduced or for placement on an automatic distribution list for single copies of future' draft guides in specific divisions should l

be made in writing to the U.S. Naclear Regulatory Commission, Washington, DC 20555, Attention:

1 office of Administration, Distribution and Mail Services Section.

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l STANDARD REVIEW PLAN FOR LICENSE" APPLICATIONS i

FOR THE USE OF RADIOACTIVE MATERIALS IN CALIBRATING RADIATION SURVEY AND -MONITORING INSTRUMENTS '

TABLE OF CONTENTS l

Section

.Page l

1.

INTRODUCTION 1

1.1 Purpose of Guide 1

1.2 Applicable Regulations 2

1.3 As Low As Is Reasonably Achievable (ALARA) Principle 3

1.4 Transportation 4

2.

FILING AN APPLICATION 5

2.1 Where to File 5

2.2 How to File 7

3.

CONTENTS OF AN APPLICATION 11 Item 1 - License Information.

11 Item 2 - Name and Mailing Address of Applicant 11 Item 3 - Address (es) Where Licensed Material Will Be j

Used og osses d

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Item 4 -

e of 2 rson d Be Codtp'cted t this plicathon

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Item 5 - Radioactive Material to Be Possessed 13 Item 6 - Purpose (s) for Which Licensed Material Will Be j

Used.

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Item 7 - Individuals Responsible for Radiation Safety-

-Their Training and Experience.

17 Item 8 - Training for Individuals Working in or Frequenting Restricted Areas 20 Item 9 - Facilities and Equipment 21 Item 10 - Radiation Safety Program 24 10.1 Personnel Monitoring Equipment 25 10.2 Monitoring of Internal Dose 27

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10.3 Radiation Detection Instruments and Instrument Calibration 27 10.4 Operating and Emergency Procedures 29 10.5 Leak-Testing.

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Item 11 - Waste Management 31 Item 12 - License Fees 31 Item 13 - Certification 32

4. AMENDMENTS TO A LICENSE 32

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5. RENEWAL OF A LICENSE.............,.33 DRAFT REGULATORY ANALYSIS FOR THE GUIDE!..

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t TABLE OF CONTENTS)- Continued '

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APPENDICES' A.

FORM 313,' APPLICATION FOR MATERIAL L'ICENSE..

A-1 i

FORM 314, CERTIFICATE OF DISPOSITION l.OF MATERIALS.-

.A-2 B. GENERAL PERFORMANCE CRITERIA ~FOR CALIBRATION LABORATORIES B-1

1. Organization and Management B-1

2. Quality System, Audit, and Review".

B-2

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Personnel.

B-6

4. Accommodation and Environment B-6 j

5. Equipment B-7

6. Measurement Traceability and Calibration B-8 7.

Calibration Methods B-9 L

8. Handling of Calibration Items B-10 l

9. Records B-12 l

10. Certificates and Reports B-12 1

11. Subcontracting of Calibration B-16

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12. Outside Support Services and Supplies B.......

13. Complaints B-17 i

ION O h E GEh5b PERFORMANCE-C. AMPLIFICAT O.AND ERPRE CRITERIA F4W CALIBRAT-ION TOR 4ES C-1 I.

Specific Criteria for Gamma-Ray Calibrations C-1 Quality System, Audit, and Review.

C-1 Accommodation and Environment C-2 Equipment C-2 Calibration Methods C-4 Certificates and Reports C-5

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II. Specific Criteria for Beta-Particle Calibrations C-5 l

Quality System, Audit, and Review C-5 l

Equipment C-5 l

Measurement Traceability and Calibration C-8 l

Calibration Methods C-7 Certificates and Reports C-10 III. Specific Criteria for Neutron Calibrations C-11 Quality System, Audit, and Review.

C-11 l

Accommodation and Environment C-11 Equipment.

C-11 Measurement Traceability and Calibration C-13 Calibration Methods C-13 Certificates and Reports C-14 j

Quality System, Audit, and Review C-15

i Equipment C-15

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Measurement Traceability and Calibration C-16 l

Calibration Methods.

C-16 l

Certificates and Reports C-17 I

i D. CHECKLIST FOR COMMERCIAL CALIBRATION SERVICES APPLICATION D-1 e

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STANDARD REVIEW PLAN FOR LICENSE APPLICATIONS FOR THE USE OF RADIOACTIVE MATERIALS IN i

CALIBRATING RADIATION SURVEY AND MONITORING INSTRUMENTS r

1.

INTRODUCTION 1.1 PURPOSE OF GUIDE.

The purpose of this regulatory guide is to provide ^'

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i assistance to applicants and licensees <in preparing applications 1

for new licenses, license amendments, and', license' renewals for the.use of radioactive material in commercial calibration

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services for NRC or Agreement State licensees. The services l

covered by this guide are the calibration of radiation survey and monitoring instruments.

Since many of the periodic calibrations of NRC licensees' survey'and monitoring instruments are obtained from commercial calibration services, the NRC must rely upon thhse commercial services to provide calibrations with adequate quality.

atishexist Services shou _d nati np per rmance criteria forcalibrati"onlaborktries.

Yhisregulatoryguidesummarizes the general performance criteria presently used by three national programs (the Health Physics Society, the National Voluntary.

Laboratory Accreditation Program (NVLAP), and the Conference of Radiation Control Program Directors).

After you are issued a license, you must conduct your program in accordance with (1) the statements, representations, and procedures contained in your application, (2) the terms and conditions of the license, and (3) the NRC's regulations. The information you provide in your application should be clear, specific, and accurate.

l Reviewer's Notes I

Notes for reviewers are inserted throughout this guide 1

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These notes I

-are indented to stand out from.the informationlpr'vided o

to the applicant in Regulatory Guide 10

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This licensing guide and-standard review plan!are*

intended to assist, but not to complicatd'or.interferet with, the issuance of specifi6 licenses udde'r)10(CFR

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30.33.

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..,f On January 1, 1994, there were estimated to be about 73L;NRC f

specific licensees authorized to commercially,calibratet

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l survey and monitoring instruments.

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.1.'2 APPLICABLE REGULATIONS i

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NRC regulations applicable to the specified dalibration services are in 10 CFR Part 2,

" Rules of Practice for Domestic l

Licensing Proceedings and Issuance of Orders";-10 CFR Part 19,

" Notices, Instructions and Reports to Workers; Inspections and Investigations"; 10 CFR Part 20, " Standards for Protection Against Radiation"; 10 CFR Part 21, " Reporting of Defects and l

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" Rule f Gen Applicability Noncompliance to Domestic L'1 censing"o Byprod ct mag rial"; TD CFR Part 40,;"

Domestic Licensing of Source Material"; 10 CFR Part 70, " Domestic i

Licensing of Special Nuclear Material"; 10 CFR Part 71,

" Packaging and Transportation of Radioactive Material"; 10 CFR Part 150, " Exemptions and Continued Authority in Agreement States.

and in Offshore Waters under Section 274"; 10 CFR Part 170, " Fees l

for Facilities, Materials, Import and Export Licenses, and Other

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Regulatory Services Under the Atomic Energy Act of 1954, as j,

4 Amended"; and 10 CFR Part 171, " Annual Fees for Reactor

-Operating Licenses and Materials Licenses, Including Holders of 1

I Certificates of Compliance, Registrations, and Quality Assurance Programs and Government Agencies Licensed by NRC".

Before preparing your application for a license to use radioactive materials for the specified calibration s~ervices, you I

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F should be acquainted with the applicable regulations.

Single copies of a specific NRC regulation may be obtained without cost l

from the Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington DC 20555, or from your NRC Regional Office that is identified in Section 2 of this guide.

A bound volume of NRC regulations may be purchased from the U.S. Government Printing Office, Superintendent of Documents, Mail Stop: SSOP, Washington DC 20402-9328.

This guide identifies the information needed to complete NRC Form 313 for application for a license for the use of radioactive material in certain calibration services. The information collection requirements in NRC Form 313=have been cleared under OMB Clearance No. 3150-0120.

1.3 AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PRINCIPLE 4

The NRC'.a egulation, 10._CFR Par "S[.andardsfor ProtectionAgapstRa

tion, as lo ej recomm nded ' that persons engaged in activities under licenses issued by NRC should, in addition to complying with exposure limits in Part 20, make every reasonable achievable (ALARA).

This recommendation has been credited with helping to maintain occupational doses and doses to members of the public significantly below the regulatory limits.

Effective January 1, 1994, the above recommendation was incorporated into a Part 20 requirement that

...The license i

shall use, to the extent practicable, procedures and engineering controls based upon souna radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA)."

The licensee is required to develop, document, and implement a radiation protection program that includes ALARA considerations.

l (Reference 20.1101).

A copy of thie document need not be 3

l submitted as part of the application for license but the document should be available for review by NRC personnel when inspecting a licensee's program.

l Regulatory Guide 8.10,

" Operating Philosophy for maintaining Occupational Exposures as Low as is Reasonably Achievable," may be useful in developing an ALARA Program.1 The program must cover all the licensee's activities which may include installing, testing and servicing of devices.

The program should include consideration of doses to members of the public.

For example, the licensee's procedures for replacing a source at a customer's facility should provide for excluding unneeded personnel from the immediate area while the source is in an unshielded condition.

J 1.4 TRANSPORTATION This regulatory guide does not cover detailed requirements for the transportation of licensed material.

The NRC's transportati equirements ar containep in g FR Part 71 which equiefents qual th assurjtnce, packaging, establishes ( )

o preparation for shipment, end transportation of licensed material and (2) procedures and standards for NRC approval'of packaging l

and shipping procedures for fissile material and for a quantity of licensed material in excess of a " Type-A quantity" (i.e.,

exceeding A1 and A2 as defined in S 71.4 of 10 CFR Part 71).

1Copies of issued guides may be purchased from the Government Printing Office at the current GPG price.

Information on current GPO prices may be obtained by contacting The Superintendent of Documents, NRC Sales, Post Office Box 37082, Washington, DC 20013-7082, telephone (202) 512-2249 or 2409.

l Issued guides may also be purchased from the National Technical Information l

Service on a standing order basis.

Details on this service may be obtained by writing NTIS, 5285 Port Royal Road, Springfield, VA 22161.

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i Two requirements for transportation of sources are particularly important with respect to those sources that are l

transported by the user (shipper).

The manufacturer or.

I distributor of the source should be prepared'to advise and supply-l l

the shipper (user) with the following:

1.

'A copy of the safety analysis, including documentation:

i of the tests, demonstrating that.the sealed source i

meets the "special form" requirements of NRC/ DOT transport regulations (SS 71.75 and 71.77 of 10 CFR j.

Part 71; SS 173.469 and 173.476 of 49 CFR Part 173).

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This is not required; however, in cases where A1 equals A2 and the source is not described.on the shipping i

documents as "special form."

2.

If an Al or A2 quantity of radioactive material is l

involved, a copy of the documentation on'the tests and engineeringevaluationorcomparadiveldatashowind,that j

the package design meets the' requirements of a DOT 4

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sper.icati.o 7A pa age l

49 CF Part }{,3).

~ (segaray 173.415(a)"of

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Shippers of licensed material are required to maintain? the above documents on file for 1 year after any shipmens. 'It is therefore important that the manufacturer or distributor' supply the shipper (user) with this information.

2.

FILING AN APPLICATION 2.1 WHERE TO FILE If you wish to possess or use licensed material under specific license on Federal property or in any state subject to NRC jurisdiction, you should file your application with the NRC i.

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Regional Office for the state in which the material will be possessed or.used.

The four Regional Offices and their respective areas for licensing purposes are given in Figure 1.

Twenty-nine states to date have entered into agreements with

.the NRC that give them the authority to license radioactive materials used or possessed within their borders, except on Federal property..These states are called Agreement States and are shown in figure 2.

A current list of Agreement' States (including the names, addresses, and telephone numbers of

. responsible officials) may be obtained upon request'from NRC's Regional Offices or from the Medical, AchdeNic and Commeycial,Use Safety' Branch, U.S. NuclearRegulatory[ Commission, Washington, D.C.

20555.

If you are a non-Federaliorganizatiod,that,wisheskt.b possess or use licensed material?under a specific (l'icense in one.

of these Agreement States, you shoul'd.c.ontact the responsible

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officials in that state for guidance on preparing'your application and your application should be filed:wibhith'e state officials and.

t wi he NR e'ulations of the' Agreement Under reci ocit rovi s in 4 g States and the NRC, a person holding a specific license in one jurisdiction is granted a general license to conduct"the same activity in other jurisdictions.

The NRC.'s general l license'for recognition'of Agreement State issued specific licenses is in Section.150.20 of CFR Part 150 Each Agreement State's regulations contain a section that is comparable to Section

.150.20 and provides a general license to a holder of a specific license issued by the NRC.

The terms and conditions of the general license in Section 150.20 are typical of the terms and conditions of an Agreement State's general license for recognition of a specific license issued by the NRC.

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2.2 HOW TO FILE I

i You, as the applicant for a materials license issued by the NRC should complete NRC~ Form 313 (see Appendix A to this guide).

l You should complete Items 1 through 4, 12 and 13 on the form itself.

For Items 5 through 11, submit the required information on supplementary pages.

Each separate sheet or document submitted as part of the application should be identified and keyed ~to the item number on the form to which it refers.

All typed'pages, sketches, and, if possible, drawings should be on 8-1/2 x 11 inch paper to facilitate handling and review.

If larger drawings are necessary, they should be folded to 8-1/2 x 11 inches.

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Ibte: Alaska ard itsaii are inchrbd in Rgicn IV.

Uhe Virgin Islands ard Puerto Rico are incluirl in Rgicn II.

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475 A13Errble Idd, King cf Prussia, IA 19106-1415 215-337-5000 II 101 Men St., ante 2900, Atlanta, CA 30323 404-331-4503 III 799 lbweelt Ibri, Glen Ellyn, IL 60137 708-790-5500 IV 611 Rycn P]aza Dr., alite 400, Arlirgtal 'IX 76011-8064 817-860-8100 ngare 1.

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i Ycn drsild amp 1Fra all item in tle qplfenHen in afficiart dtail fcr tle NC to rhmire the y1r eg2ipert, fnciliHm, tIainirg ad egerierre, ad YMitien mf*y l

l guy.au are %*a to prrtret health ard minimi2e chtryr to life cr gwty.

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j Plesee rrte the licmse Wireiers are anilabla fcr review by tre gswral phlir in the NC phlin th, ret Fbats.

Ib rrt subtit prmrieavy iA.mi sen miem it is ahmlienly re -ry.

If abnittal cf arh idumJcn is rs-ry, fallcw the rirr5 vim j

in S 2.790 cf 10 GR Ibrt 2. Failiire to fn11ew this ptrrwiire nay result in dimleaw cf tin prmrienry ir nrneien to the phlic cr ahtatial chlays in 1-o +irg yar e

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l Ib rrt abnit peraral idum ten ah,r. y2r irdiviani erplqees miem it is re - y.

Ftr eatple, a rhrrittien cf tle trainirg ad eperdare cf irdivianin 1

l struld be abnittsr1 to d2ushcie each irdivian1's ability to nange raa4*ien sfety 1

i rugam cr to w2k sfely with rMiewtive negriala.

Ibever, Irne alks ard ralri+rre nnbers druld rrt be subnitted.

rem cf birth, Mal Security nnbers, ad rMieien chee istuui ten frr irdivia n1 siployms druld be abnitted cnly if i

l Ycn sh,ild ptgare y2r Wireien in triplie*a, smi tm erpim to tle NC ard l

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AGREEMENT STATE PROGRAM

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a as 29 AGREEMENT STATES (approximateiy 15,000 iicenses) i 21 NON-AGREEMENT STATES (approximateiy 7,000 licenses)

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