ML20198G198

Consolidated Guidance About Materials Licenses.Applications for Sealed Source and Device Evaluation and Registration. Draft Report for Comment

ML20198G198
Person / Time
Issue date:	09/30/1997
From:	Steven Baggett, Doug Broaddus, Michele Burgess, Compton E, John Lubinski, Randall K, Thomas Rich, Beverly Smith NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-1556, NUREG-1556-DRFT, NUREG-1556-V3-DRF-FC, NUDOCS 9801120269
Download: ML20198G198 (134)

Text

,;

B

'u Q

~"4 3

- llf.

vy,

-; W,

(

f I

$ hkrh.hdhs'fk f.

).

gy) byf

%:3.

g,

, f. p$]ghQ, g

q f$

A n.

x w.,.e m % a.

n4 u z4, Ik M+h@;$e "m"emu p5k a

y M

W pg dh wey%e p~,uy\\\\\\ m 1.

4gssp~d 3

nn

-m nm t,

QE{(I[yl O k:yy, j,fjk ah[mu,sg:g'sg[ijdpw Riff.j

+ b(

-g

-p bgg J

~ pjceQ" y ' gg gA 3q gg e

m,=a

..,3 inyhrdisg%gfM 0f h cjyn 9801120269 970930

)f'<{*U;![Q6G!jpg S-P OR NUREG

't t

((;pf IS56 R PDR

=

(* q,

- i

', e

'8',,

.. g'..

• * *+ i.,,f"' s ' '. / ' t,,. M,., d. ' '

.c; g

. =,*

,f,

. '. I. r/W +a L.

'es c,..

i: "p

. S,,

ll p.

.,, ' g

.., N : ',!,<.

i.<

i w

, l.h 34, f [ ' W,*,.,. g I I.

i.,

... i,,['e' ' g

.. ' f#

, ' -,i** "..)- 'g

.j.

< ~ A.f.,i. 7.h. ta'h q t' g '.-

., e v...., ',te p

't

.... rg,'M.i 4

? '9 4.-

'; -y

.)

,i y

i

,a,* s g * '

.c.

-.'. i

. t 4

4 e

.' q o,"-o

.. '.. y,

. (#. +,.,, -.

s

,.3*

. ( j'.

ee

• 7s.

t J

p c.( -

. [,.

i t'.

.8 c'

?#

• *'i..>'

a 7,,;.. -

a pi

.,i.

og n,,

,,p

~,'

.t,

'.,. s i

.i

. <t 4

1. 4 l. $}

I

.'.=.y' *, ' '

e.

','.'s

- ' '. '.,r l3...t f

b

-, 9

.,s

.s(i, e

. ;p a

'. :9 :.

t

[

.'. - ' '. " ' L

,A

...,*.?n]

.ll

'.. " '.,.,,.fi.',.

').

-,r.

t.*.,.,*

,...e,.

n.

...**, d ci, f*.

. 1 e

'.".D' 2

3' l,.

• f... 4.. g

!g.,... ", '

s.

',4

r,'

. j f T *~

'.i s.

,',e 1 l l, }*., ', f; ' <, ' ' ~,.,' * ', f 'l -. '

t l

?,i ;) ,

e.

[,.

< :. '- l.. J 4

', ' y t,;,

%-}

c.

v

.. x q.-

g.

.ict' g.

z..{g..;..

q. 4.%...

', ',Q

,.l [*,,,?j

$,", f *. fe'..,. ib. ',,,, '

I, g+

k:q 4 l"

"E.p. _

r

4..

• f,,

' (*} ',' 3., ' ' - '

. .. :... I f..

. j.; $ -.

r.

g e's

, Ap[e.,, ', < '

,'\\

'k';'4 s

e.,.

=',h g.4

P..' '. 'i 7*/ a.']

i

~,

., ',D[

Y i

'c.,

9.*

d Ii

} ,4,",,F r,.

{c,',

4..% 8 i

'A

,.'a- '.b' WI

.f*. p

'#b

h.,. ' I

\\-

5 1.

'a

?'

,(

T'k'

-Q ' '.- * - f/

k 1

.l

. ~,'.

O. ; +is'

• h h;} het. 6..

u..},

8

g*

'. /,,,

4

',s..

t-s

?-

'u.

,.. e

+

'., t. " #g,..s. ;.1

../

g 4.

n.

gi,

,*g.

, s.

.s..*,8.e.. #,... i;,

.t -. %*1.,

y.,

ev p

..5

.6

-o

(..',,4.-

N,

y".

9..,. i. v... oy-, (W

", al

. g - :.

i.

e

(

ab, t

-4 r i

m

.ai 4

e I.[

1 t "

l,

[t 4

i.

a c.,

c ntl.....,. ae4 N g.

y - a

,..f.'

1-

',.,Ij,

y _, \\.v..

• j

$ 4" 'd f - is,4

',,, ll 't,, {,, #

y.y,,,., 1}

',i'.",e

,1

.a

'1 [ (b

), b 4;.

NU. '

.b., i,,, 0 e.

4 WN':-[Yj.: e.,d ' ' $,", ' #g....,.

.f.

a,,f

.., ',' j, 4, s.,,

? '.

i.

'f 4%.,,' i ' " " Y*'*'

. 4

', 5 e p

' T 'Y ',' D P } '

' M M 8.l. "'I Q. fi %[q'i I;'.'j' a,

'C',

'y**

'f...,,, c,,;,

..,.in.

ie!..

.', },,j..

4,4 6;. {. 7, j". l Il ;

.4 '

' J.,

, ;. 5.}

j s

1 e,*i.1 -, 3 l

pic *". ' i i *,

e % ', '

,t

' '.*.,.l.

.e s

'e'<

'a-j

\\ ' :., j tb,! '.rg e

y

[%,, w i,,

a

'U ' '.'

,A,, ?4 '.

J',

3,"

f ',,, s.,

is..,

.g

. +

c 9 y 4.. '+ :.

',, s w' '

', l _ a,.se,,,

.ci.,vj

, in _,-,. ;

'.o;.-,.,.

,,,[.,'*

. p. :.. $,

..g

.i.,.i ;.*.

', g,1. '. 4

'l.,.j g..,.?j..., ;,

i.

u0.

9 s

.)

u i

tm...: <*.'.' -

.g

.. ' '.,c a,..,4 :

.k').f 4

, M '. I.

i.

t.'a,..

1 f ' ' '-

U,

'./ J ', I

[

't, f,

' I

..s y-so...:

d.

t

.. v

.s

'4

.ea - '

7

,.f

• !. s : ' ;*. ' 'L

'I ' ' -

_.Q.,J*,_,'

{'

\\,' ' :

e-4' ' ed.k - f N

• .N' e.

I I.,';.. g '

';. A.

K,

.t.,,

.a t"

.. ' ' '.. /, '

'}-

e

.,.,,y e.

.m"$'. l,*

ie

.. (

.',J,_

, ;... ic 1m. /

, // +

f. -

.Y

.8.'

*,%..,e

. ' ' ' = ' [, ( ' [j ] '..e,.

e,. [

• f.

3 j,,,, : a,,',,,,,,

. ' ; t ' i.,

s

-h,,

.p

'. +

E I..

' [,

'. \\, f

*i..

' '. '. ' l ..' l:. Y ' '

.0

t. ' f. ' l, ',g. ] 1"

.,, y ',m,,,,d,', 3./ 4' h ', ' j' *q? p.g,d Q' 4 l ;3.',j. y',';c

..g

,,W

,4

. l,,

,jl., ],

e f ' 4* s 8. T,,-

yy,,h* *. f.. y 7. 'f.j ' p.

• (.

4

..i '

g'

7.. 'f.

, s,

..,-l

' bl'.w wh P. J :

V P

, s Y. ', ' 't ;

,e.

'es-f.'.. '. +

i

't'*..n'-

,?.

L,

,ll.

• 4i -.

e, 1

3 c

' '.'',; - e

' ' k

.p.

• .,1

. I g[ajlk,dk h ',. 'I w

y'

• I,

/ (:.}

p, h#(3 I ' ',f ',

• r -

g

• .*'3.Y

'- -,N j'

2 w.

y

• .,,... g v.,.

.AU

.s

f.g. %'p*]lga..l ",' f ' ] ? 1., *' '

• ,b

c'.','

e. g,pll!l,k; _

..,,, (,

j,

f k1

, I,. *

.? AN ' '

?lqiW

..g 8' i. ;,-., -t [. s' T ?I '

E

^ "' ' ^'

E l?

a dQ.%

1.g.q:

s'

':,' l I '" 'a 0 - / '," 4 " L'..

- " Mc ) Il.l:c; 4 "

S.".. l hp% i W w::mr.w,.... m a. P;M.,e g.,.: nW~ v.c.M. n.ti' 4!.!%.

hh[Q,ll ',h ' ',x;,c N r ;. r.. f J v '\\. - ' :

i

','"' ". -..c

/1.P ' 4 O '.?M'0 & T aL

.. u h

Q M.. o. e, &

W--

n m.m.s;. 43,m.*

n

.c,, :.

s e.S n s.-

n g

f j f a. h..

5 i

' ' 'n. ;

J

'C

'*D

't '0:.;'.g;*h.;.nf e y'

'U'

> g 4[,qa p' e. ~;.

Av'

.., $ n..: c-:;s. i. " ::s e%..: 4 '& i - ' " i. " : * *: ' ~ l-M

b. "': ' " ' '. ' .c '.

- h */ :

.l

.m s

c l

Q i.,*,GVA.

. y 4*

, a

%w a%w..m. a.k h

A..

O wo: +..m :.. e

.o w.- 1Ne + ".'A W W. W;

.gd./.y

?

4p.a n.xm,-e,..

1

u. we. 4 <..w.

4 v

e k

hhh.

.W G f ' ~ V 'N'"1l

'?'"

h h _Q.h.'h.h 4 Afl

%l f 4

~

V l * ? R'? ?, _w(ff R hl h:d$w@$'W M.c* W 'Ti?'# %@~p@W@M h

'Y WV h

3 M

n FNWWNWWM n.

rS.,,. m~ a

.,. s

,. _ -w_.

wnww..my wga c,,

s a

N,.

s7 m

a. o hf! Tih m a

5' '".T 'M. W' $ 8

N Mkyf..f,,y.d 'n '.h.'

" 71 O'"

".'*J Pi" + U eM '" ?

[Y* [ N hpN

' f J:4 D 0; m v h. + :. % i..:p m m,e:G. ::

v:%. }. e? W $, %[

t i ;:.L[>..?.9[.3 ~ ::

(h N.jhY, }

mhhWN ?.l l f.{ -:

. % f s:' 2 % b;,+ N%QO '**'%$ k (b h.},:f.: '.&l?W >*! O*Wf V' W ';':

R:

h hh kh

5 NUREG-1556 Vol. 3.

Consolidated Guidance About Materials Licenses Applications for Sealed Source and Device 4

Evaluation and Registration I

Draft Report for Comment UcS. Nuclear Regulatory Commission Oflice of Nuclear Material Safety and Safeguards

-1.1.ubinski, S. Daggett, D, Broaddus, M. Burgess, E. Compton, K. Randall, T, Rich, D. Smith '

i

~

4 ysg

. ((!-[,7 "]"[ ]

==-

1ss a con M

p{

ti I

k j

k AVAILABILfW NOTICE q

Availability of Reference Materiald Cited in NRC Publications Most, documents cited in.NRC publications will be available from one of the following sourcesi i

<1 The NRC Publio Document Room, 2120 L Street, NW., Lower Level, Washin; ton, DC 20555-0001 2.

The Superintendent of Documents, U.S. Govemment Printing Nfice, P. O. Box 37082; Washington, DC_ 20402 9328 3.

The National Technical information Service, Springfield VA 22161-0002-Although the listing that follows represents the majority of documents cited in NRC publica '-

' tions, it is not intended to be exhaustive. -

Heferenced documents available for inspection and copyl.)g for a fee from the NRC Public Document Room include NRC c0rrespondence and internal NRC memoranda: NRC bulletins, circulars ' information notices, inspection and investigation notices; licensee event reports; i

vendor reports and correspondence; Commission papersi and applicant and licensee docu-ments and correspondence.

1The following documents in the NUREG series ars available for purchase from the Government -

5 Printing Office: ~ formal NRC staff ord contractor reports, NRC sponsored conference pro-coedings, international agreement reports, grantee reports, and NRC booklets and bro-E chures.- Also available are regulatory guides, NRC regulations in the Code of Federal Regula-tions, and Nuclear Regulatory Commission Issuances.

- Documents available from the National Technical information Service include NUREG-series reports and technical reports prepared by other Federal agencies and reports prepared by the Atomio Energy Commission, forerunner agwy to the Nuclear Regulatory Commission.1 a

Documents available from public and special technical librarios include all open literature Items, such as br oks, journal articles, and transactions. Federal Replster notices, Federal and State legislation, and congressional reports can usually be obtained from these libraries.

Documents such as theses, dissertations, foreign reports and translations, and non NRC con-forence proceedings are available for purchase from the organization sponsoring the publica-

' tion cited.

Single copies of NRC draft reports are available free, to the extent of supply, upon written request to the Office of Administration, Distribution and Mall Services Sectio'n, U.S. Nuclear Regulatory Commission. Washington DC 20555-0001.-

Coples of Industry codes and standards used in a substantive manner in the NRC regulatory -

Stocess are maintained at the NRC Ubrary, Two White Flint North.11545 Rockville Pike, Rock-

.ville, MD 20852-2738, for use by the public. Codes and standards are usually copyrighted -

and may be purchased from the orig lnating organization or, if they are American National Standards, from the American National Standards Institute,- 1430 Broadway, New York, NY f10018-3308.

l e

y e-y u

y v

w-

~

---

g.

1 NUREG-1556 Vol. 3 Consolidated Guidance About Materials Licenses Applications for Scaled Source and Device Evaluation and Registration Draft Report for Conunent Manuscript Completed: September 1997 Date Published: September 1997 Prepared by J. Lubinski, S. Baggett, D. Ilroaddus, M. Burgess, E. Compton, K. Randall, T. Rich, B. Smith Division ofIndustrial and Medical Nuclear Safety omce of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Wcshington, DC 20555-0001

,p*** "*%

[

- COMMENTS ON DRAFT REPORT

]

1 Any interested party may submit comments on this report for consideration by the NRC staff.

Please specify the report number, draft NUREG 1556, Vol. 3,in your comments, and send them by the duc date published in the Federal Register notice to:

[

Chief, Rules Review and Directives Branch Office of Administration Mail Stop T6 DS9 Washingtou, DC 20555 0001

- [

l I

i f

i t

4 i

l,

[

1 I

1 i

we~wrn,,s-v.~

,-,,---es,,.

en.,-

,-+

Abstract As part ofits redesign of the materials licensing process, the United States Nuclear Regulatory Commissmn (NRC) is consolidating and updating numerous guidance documents into a single cornprehensive repository as described in NUREG 1539," Methodology and Findings of the NRCs Materials Licensing Process Redesign," and dran NLREG 1541," Process and Design for Consolidating and Updating Materials Licensing Guidance." Draft NUREG 1556, Vol. 3,

" Consolidated Guidance about Materials Licenses: Applications for Scaled Source and Device Evaluation and Registration," dated September 1997,is designed to provide applicants for requests for a scaled source or device safety evaluations, and reviewers of such requests, with the infonnation and materials necessary to rnake detenninations that the products are acceptable for licensing purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, certain administrative procedures to be followed, infonnation on how to perfonn the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

'Ihis document combines the guidance previously found in NUREG-1550," Standard Review Plan for Applications for Scaled Source and Device Evaluations and Registrations," Regulatory Guide 10.10," Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Ilyproduct Material," Regulatory Guide 10.11," Guide ihr the Preparation of Applications for Radiation Safety Evaluation and Registration of Scaled Sources Containing Ilyproduct Material," and the Oflice of Nuclear Material Safety and Safeguards Policy and Guidance Directives 84 22,"What Source and Device Designs lhquire an Evaluation," and 84 5," Source and Device Evaluation Technical Assistance Request."

Note that this domnent is strictly for public comment and NOT for use in preparation or review of applications fut ded source and device evaluations until it is published in final fonn.

iii NUREG-1556, Vol. 3 (draft)

Contents Page A ll STRA CT..................................................... ill FO R E WO RD..................................................... i x ACK NOWLEDG M ENTS............................................ xi AllllRE VI AT10N S................................................. xil 1 PURPOSE OF DRAFT REPORT.........................

11 2 AG REEM ENT STATES..........................................

2 1 3 M ANAGEMENT RESPONSilllLITY.................................

3 1 4 APPLICAllLE REGULATIONS....................................

4-1 4.1 Selfluminous Products Containing Tritium, Krypton.85, or Promethium 147 for Use by Persons Exempt from Licensing Requirements........... 42 4.2 Gas and Aerosol Detectors Containing Ilyproduct Material for Use by Persons Exempt from Licensing Requirements................. 4-4 4.3 Devices Used under the General License in 10 CFR 31.5.............

4-4 4.4 Luminous Safety Devices Used in Aircran under 10 CFR 31.7.........

4 5 4.5 Ice Detection Devices Containing Strontium 90....................

4 6 4.6 Radiography Equipment..................................... 46 4.7 Well Logging Equipment.................................... 4-7

4. 8 1 rrad i a t o rs.............................................. 48 4.9 Scaled Sources and Devices for Medical Use

.....................49 5 GENERAL POLICIES AND PROCEDURES...........................

5 1

$.1 Scaled Source and Device Designs That Do Not Require Evaluation by IMNS 51 5.2 Custom Users 53 5.3 As Low As is Reasonably Achievable........................... 53 5.4 Naturally Occurring or Accelerator Produced Radioactive Material.......

5 3 5.5 Foreign Vendors........................................

5-4 5.6 Use of International or Foreign Standards......................... 54 5.7 FDA NRC Memorandum of Understanding.........,..,.........

5-5 5.8 Computer Sonware................

56 5.9 Registration Certincate Revocation 5-6 5.10 l nc i d e n t s.............................................. 56 5.11 Proprietary Information 57 5.12 Transportation................................

58 6 1 10 W TO F I L E................................................

6-1 7 Wi lE RE TO F I L E..............................................

7-1 8 REGISTRATION F EES...................................

81 9 DOCU M ENT FLO W............................................

9-1 9.1 Application Receipt and Assignment to a Reviewer.....,...........

91 9.2 Reviewer's Responsibilities................................... 91 9.3 Distribution of Completed Certi0 cates........................... 92 9.4 Inclusion in the Scaled Source and Device Computerized Registration System 92 v

NUREG 1556, Vol. 3 (dran)

Contents (continued)

Page 10 CONTENTS OF Tilli APPLICATION AND Tile REVIEW PROCESS........ 10-1 10 1 10.1 Sununary information 10.2 Cond itions o f Use....................................... 10-4 10.3 construction of the Product......

10 5

10. 4 1.a be l i n g.......................

10-8 10.5 Prototype Testing

......................................1010 10.6 Radiation Pro 0les.....................................

10 14 10.7 Quality Control and Quality Assurance........................

1015 10.8 Installation, Servicing, and instructions to Users..................

1016 10.9 Final livaluation and Concurrence........................... 10 18 11 DEFICIENCIES IN Tile APPL.lCATION............................. 11 1 11.1 Sending Deficiency 1.etters to Applicants Il 1 11.2 Meetings with Applicants.................................. Il 2 11.3 Use of the Telephone or Electronic Mail to obtain Additional I n form at ion...................................

11 2 11.4 Response Time Extensions................................. 11-2 12 CONTENTS OF Tile CERTIFICATE.......

12-1 12 1 12.1 Ileader........

12.2 First Page information.................................... 12-1 12.3 Desc ri pt ion............................................ 12-1 12 2 12.4 Labeling...............

12.5 Diagrams...........................

12 2 12.6 Conditions of Normal Use

................................122 12.7 Prototype Testing 12 2 12.8 External Radiation 1.evels.................................. 12-3 12.9 Quality Assurance and Control..

12 3 12.101. imitations and Other Considerations of Use....

12-3 12.11 Saf ety Analysis Summary................................. 12-4 12.12 References 12-4 12.13 1ssuing Agency.........................

12 4 12.14 A t t ac h m ent s.......................................... 12-5 12.15 Dimensions and Use of Dual Units....................

12-5 13 MODIFICATIONS TO EXISTING REGISTRATION CERTIFICATES......

13-1 13.1 Amendments.

13 1 13.2 Corrections..............

13 2 13.3 Combining !tegistration Certificates..........................

13 2 13.4 Transfers to inactive Status........

13 2 13.5 Re-activating inactive Registration Certificates......

13 3 14 IDENTIFYING AND RiiPORTING DEFECTS AND NONCOMPl. LANCE AS Rl! QUIRED llY 10 CFR P ART 21............................... 14-1 15 G l.O S S A R Y...................................

15-!

l NUREG 1556. Vol. 3 (draft) vi

- ~. -

1 Contents (continued) 1 LIST OF APPENDICES A'

Memoranda between C. Paperiello and S. Treby Regarding Licensing of Scaled Sources and Devices Evaluated and Registered by Agreement States B

Checklist for Requests to Withhold Information from Public Disclosure z

C

. Application and Review Checklist D

Memorandum from R. Scroggins Regarding Working on Applications Prior to Receipt of Fees E

. Principal Use Codes and Del'mitions F

Standard Reference Materials G

Industry and Concensus Standards 11' Standard Registration Certificate Formats 1'

Assigning Registration Certificate Numbers J

List of Approved Well Logging Sources LIST OF TABLES Page Table 2.1 Who Evaluates Scaled Sources and Devices?......................

2-3 LIST OF FIGURES Page F i u re 2.1 U. S. M a p...............................................

2-3 3

Figure 4.1 Watches and Aiming Sights................... -..............

4-3 Figure 4.2 Smoke and Chemical Agent Detectors.......................,

4-3 Figure 4.310 CFR 31.5 General License 4-5 Figure 4.410 CFR 31.7 General License 4-6 Figure 4.5 Radiography Equipment..................................... 4-7 Figure 4.6 Well. Logging Equipment,................................... 4-8

. Figure 4.71rradiators 4-8

- Figure 5.1 Calibration and Reference Sources.............................

5-1 Figure 5.2 Map of the World........................................

5-4 Figure 5.3 Computer Software........................................ 5-6 Figure 5.4 Packaging and Transportation 5-8 Figure 10.1-Graph of Suggested Radiation Profiles........................

10-14 Figure 10.2 Installation and Servicing of Devices.................,,......

10-18

-vii NUREG-1556, Vol. 3 (draft)

.m 1

I FOREWORD'-

1

~

~ The NACis using Business Process Redesign techniques to redesign its materials licensing -

1 process. This effort is _ described in NUREG 1539. A critical element of the new process is -

j consolidating and updat!ag numerous guidance documents into a NUREG-series of repons.

I Below is a listing of volumes currently included in the NUREG-1556 series:

Vol.m

. Volume Title' Status:

No.

1

1; Program Specific Guidance About Portable Gauge Licenses Final Report j

~

2_

Program-Specific Guidance About Radiography Licenses Draft for Comment -

3<

_ Applications for Scaled Source and Device Evaluation and.

Draft for Comment.

Registration

- Draft NUREG-1556, Vol. 3,"Consolidateu Guidance about Materials Licenses: Applications for

Scaled Source and Device Evaluation and Registration," dated September 1997, provides

[

applicants requesting a sealed source or device safety evaluation,'and reviewers of such requests, with the information and materials necessary to make determinations that the products are acceptable for licensing purposes. It pmvides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, certain administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certiicate holder.

A team composed ofNRC headquarters staff prepared draft NUREG 1556, Vol. 3, drawing on

. its collective experience in radiation safety in general and as speccally applied to sealed source and devices designs, and the experience gained through development and publication of NUREG-1550," Standard Review Plan for Applications for Scaled Source and Device Evaluations and Registrations," that was published in 1996.

Draft NUREG-1556,.Vol. 3, represents a step in the transition from the current paper-based process to the new electronic process. This document is available electronically by visiting the 1

NRC's Home Page (Aqp:/Amw. arc. gov) and choosing Nuclear Materials, then Business Process

- R_edesign Project, then Library, and men draft NUREG-1556, Vol. 3. Text shown in bold italics indicates information that will be linked electronically allowing the user, by simply " pointing and clicking," to see the actual text of regulations, acronyms and abbreviations, and other -

referenced documents?

iThis draft guide is being distributed for comment and is NOT for use in preparation or review of applications for scaled source and device evaluaiions until it is published in final form. Please g'

' submit comments within 60 days ofits publicationc Comments r :ceived during the comment j

ix NUREG-1556, Vol. 3 (draft) v

period on this draft guide will be considered in developing the final guide. After the final guide is published, applicants may use the document in preparation of applications for seat 2 source and device evaluations and the NRC staff will use it in its review of requests for sealed source and device evaluations.

Address comments to: Chief, Rules and Directives Branch, Division of Admini...ative Services, Oflice of Administration, U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

Iland deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to diml@nrc. gov.

Draf1 NUREG-1556, Vol. 3, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this draft report are provided for information and comment only.

Donald A. Cool, Director Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards NUREG 1556, Vol. 3 (draft) x

f 't 1

i

- ACKNOWLEDGMENTS-e u-3, The writir>g team hnks the individuals listed below for assisting in the development and review of the drsft report? All participants provided valuable insights, observations, and recommendations.

Th'e team also thanks Traci S. Kime, NRC, Angela S. Case, Total Systems Solutions, Inc., and.-

Tina Jordan, Alyce Martin, and Judy Boykin, Computer Sciences Corporation.

The Participants -

Baggett, Steven _ L.

Broaddus, Douglas A.

i

, Burgess, Michele L.

3 amper, Larry W.

C

' Compton, Tiric B.

Cool, Donald A.

Lubinski, John W.

Randall,-KimBerly B.

Rich, Thomas W.

Schwartz, Maria E.

l.

Smith, Brian W.

l Vacca, Patricia C.

xi

. NUREG-1556, Vol. 5 (draft) j s

u j

l

~

.]..

ABBREVIATIONS ALARA As low As is Reasonably Achievable ANSI American National Standards ins:itute CFR Code of Federal Regulations DCD Document Control Desk FDA United States Food and Drug Administration GPO Govemment Printing Omce thins Division ofIndustrial and hiedical Nuclear Safety ISO Intemational Organization of Standardization MOU Memorandum of Understanding NARM Naturally occurring or Accelerator-produced Radioactive Material NRC United States Nuclear Regulatory Commission OC Omce of the Controller OGC Omcc of the General Counsel OSP Omce of State Programs QA Quality Assurance QC Quality Cantrol NUREG 1556, Vol. 3 (draft) xii

~ - -

i l

.1. PURPOSE OF DRAFT REPORT This draf4, NUREG provides assistance to applicants on submitting requests to the NRC for radiation safety evaluation and registration of sealed sources and devices containing byproduct 1

material._ in addition. it is designed to provide the reviewer of such requests for sealed source and device safety evaluations with guidance, information, and materials necessary to make a determination that the product is acceptable for licensing purposes. It provides the applicants and reviewers with information conceming how to file a request, a listing of the applicable regulations and industry standards, policies afTecting evaluation and registration, certain administrative procedures to be followed, infonnation on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

Rediation safety programs for the use of byproduct material as a sealed source or device are structured on the presumption that the byproduct material will not breach its containment and contaminate the environment, or unnecessarily expose individuals to radiation. This presumption depends largely upon the adequacy of the containment properties of the scaled sources or devices in withstanding the stresses imposed by the environment in which they are possessed and used.

The regulations provided in Title 10 of the Code of Federal Regulations (CFR), Section 30.32(g) -

require an applicant for a license to use a t :aled source or device to identify the sealed source or device as registered with NRCin accordance with 10 CFR 32.210 or to provide the information contained in 10 CFR 32.210. 10 CFR 32.210 provides for the registration of a product and provides a means for heving a single safety evaluation of the produ::t performed. This process allows applicants and license reviewers to reference the evaluation when licensing the product for use or distribution without having to pe-form a complete evaluation of the product for each licensing action.

The NRC maintains a registry of radiation safety information on scaled soun:es and devices containing byproduct material. Agreement States also provide information on their radiation safety evaluations to the NRC for the registry. Both the NRC and the Agreement States use the informat m in the registry. Thus a vendor needs to provide detailed information about its sealed i

source or device only to a single agency, and the results of the radiation safety evaluation will be cvailable for use in granting licensing approval to users of the device throughout the United States.

Any information collection activities mentioned in this document are contained as requirements in 10 CFR Parts 19,20,21,30,31,32,34,35,36,39,40,70, and 71, which provide the regulatory basis for this document. The information collection requirements in these parts have been cleared under Oflice of Management and Budget Clearance Nos. 3150-0044,3150-0014, 3150-0035,3150-0017,3150-0016,3150-0001,3150-0007,3150-0010,3150-0158,3150-0130, 3150-0020,3150-0009, and 3150-0008, respectively.

1-1 NUREG-1556, Vol. 3 (draft)

)

2 AGREEMENT STATES Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority for certain activities, including performing safety evaluations and registration of byproduct, source, or special nuclear materials used, possessed, or distributed by persons within their borders. A current list of Agreement Stat:s (including names, addresses,-

and telephone numbers of responsible officials) may be obtained upon request from the NRCs

- Office of State Programs (OSP).. Any applicant, other than a Federal agency or distributor of a product to persons exempt from licensing, that is located in an Agreement State and wish6s to apply for safety evaluation and registration of a sealed source or device needs to contact the responsible officials in that State for guidance on preparing an application; file these applications with State ofricials, not with the NRC. Table 2.1 provides a quick way to check on which '

agency has regulatory authority.

Three Agreement States, Iowa, North Dakota, and Utah, have voluntarily relinquished their authority to perform scaled source and device safety evaluations. Therefore, applicants and registration certificate holders located in these States are regulated by the NRCin the same manner, with respect to scaled source and device registration, as those not located in an Agreement State.

When an Agreement State issues a registration certificate, a copy of the registration certificate is forwarded to the Division ofIndustrial and Medical Nuclear Safety (IMNS) by the State. IMNS perfoe i an administrative review of each certificate that includes looking for gross errors or omissions and ensures the incluswn of all necessary information on the first page of the certificate. The certificate is incorporated into the national registry and copies are distributed to the NRC regions, all Agreement States, and appropriate Federal and intern

• nal agencies, if any administrative problems or errors are identified with an Agreement State registration certificate, they are resolved directly with the Agreement State.

Agreement Statt. regulations may vary from NRC regulations. As such, scaled sources or devices registered by an Agreement State may not have met the regulations required of an NRC licensee. In addition, the NRC may identify significant safety concerns about a sealed source or device that has been evaluated by an Agreement State, in these cases,IMNS will continue to incorporate the registration certificate into the national registry. Ilowever, a cover letter indicating why the sealed source or device is not approved for use by NRC licensees is attached to the registration certificate. IMNS will raise the safety issues with the State that issued the registration certificate and with the vendor through OSP. In addition, the NRC will attempt to obtain a listing of any NRC licensees that may have acquired the devic e and will take l

i 2-1 NUREG-1556, Vol. 3 (draft) g

appropriate action. Corrective actions to resolve the registration issues,if any. ""' % the =

- responsibility of the Agreement State.'

The above process is necessary to: (1) ensure thai NRC nse reviewers are aware of particular

NRCconcerns with the registration certificate and (2) provide other Agreement States with the

'information necessary to determine whether a license to use the scaled source or device should -

be approved. If the registration certiticates and cover letters are not included, an NRC or '

- Agreement State license reviewer may receive a' copy of the registration certificate directly from the registration certificate holder or an Agreement State and may inadvertently assume that products listed in the registration certificate are acceptable for licensing.

' This policy is described in the memorandum to OfUce of the General Counsel (OGC) dated September 3'!,' 1993, and OGC's response dated December 23,1993 (Appendix A).

= NUREG-1556, Vol. 3 (draft) 2-2 j

l l

Table 2.1 Who Evaluates Sealed Sources and Devices?

AITLICANT AND IT5 LOCATION REGULATORY AGENCY Distributor of products to persons exempt from licensing regardless of location NRC Federal agency regardless of location NRC Non Federal entity in non-Agreement State, US territory or possession NRC Non Federal entity in Agreement State at non Federally controlled site Agreement State Non-Federal entity in Agreement State at Federally <ontrolled site NOT subject to Agreement State exclusive Federal jurisdiction Non Federal entity in Aercement State at Federally-controlled site subject to NRC exclusive Federal jurisdiu.un Locations of NRC Offices and Agreement States Region IV Region til NH 3

ND }

VT 1

WA MT s

E Region l J

sD Mi MA OR 10 wy g

lA Rt IN OH NE t

N,) CT 4

UT CO DE Awy KS m

AZ NM AR p

8$SW, Sute 23T85 AK

@g 404-562 4400,1-800-5774 ;10

$4 Region 11 R7 on att 6

605'$Y35Y t

G Reg:onalOmce g Headquarters 630-829 4 500, 1 400-522-3025

$ ReidOmco y

61Yp an Plaza Drwe, Sute 400 C 30 Agreement States hdquarters y

30 1 000 800-G 42 7

00

-9677 Q 20 NonAoreemert States (approx (000 bcenses)

Re ionI Walnut Creek Flekl omce k7 A e Note Alaska and Hawad are induded 19406 1415 nut C e CA 94596-5368 R

ue Rico and Virgin 6t$337-5000,1-800-4321150 510 975-0200,1 400-882-4672 62 M 9 Figure 2.1 - U.S. Map - Location of NRC Offices and Agreement States 2-3 NUREG-1556, Vol. 3 (draft)

3 MANAGEMENT RESPONSIBILITY The NRC recognizes that efrective applicant / registration certificate holder management is vital to achieving safety and complying wt'

.,ulatory requirements. The NRC also believes that consistent compliance with its regulati

,rovides reasonable assurance that regulated activities will be conducted iccordingly. Based o.. olts of routine and special inspections oflicensed activities, the NRC has determined that ineffective management is frequently the underlying _

cause of compliance problems. Management refers to a senior-level manager who has responsibility for overseeing regulated activities.

To ensure adequate management involvement, a management representative must sign the submitted application acknowledging management's commitments and responsibility for the following:

Completeness and accuracy of records and all information provided to the NRC

. (10 CFR 30.9);

Knowledge about the contents of the application; Applying for a registration certificate amendment if the information provided in the application or contained in the certificate is modified or changed. Registration certificate holders must comply with the inforrntion in the registration certificate until the certificate is amended; and, Committing adequate resources (including space, equipment, personnel, time, and, if needed, contractors) to ensure that the registration certificate holder meets its regulatory requirements. The registration certificate holder is required to manufacture or distribute the product in accordance with: (1) the statements and representations contained in the application for safety review and registration; (2) the provisions of the registration certi ficate; and, (3) NRC regulations.

Applicants and registration certificate holders may be subject to enforcement actions due to noncompliance with regulatory requirements. For information on the NRC enforcement program, see " General Statement of Policy and Procedures for NRC Enforcement Actions,"

(NUREG-1600), which is available from the NRC upon request. NUREG 1600 is also available on the Internet. Visit NRC's llome Page (http://www.nrc.gev), choose " Nuclear Materials,"

then " Enforcement Program," " Enforcement Guidance Documents," and then " Enforcement Policy."

3-1 NUREG-1556, Vol. 3 (draft)

4 APPLICABLE REGULATIONS It is the applicant's or registration ecrtificate holder's responsibility to have up-to-date copics of applicable regulations, read them, and abide by each applicable regulation.

The following Parts of 10 CFR Chapter I contain regulations applicable to sealed source and device evaluations:

10 CFR Part 2," Rules of Practice for Domestic Licensing Proceedings and Issuance of

+

Orders" 10 CFR Part 19," Notices, instructions and Reports to Workers: Inspection and

=

Investigation" 10 CFR Part 20," Standards 1br Protection against Radiation" 10 CFR Part 21," Reporting of Defects and Noncompliance" 10 CFR Part 30," Rules of General Applicability to Domestic Licensing of Byproduct a

Material" 10 CFR Part 31," General Domestic Licenses for Byproduct Material" 10 CFR Part 32," Specific Domestic Licenses to Manufacture or Transfer Certain items

+

Containing Byproduct Material" 10 CFR Part 34," Licenses for Radiography and Radiation Safety Requirements for

+

Radiographic Operations" 10 CFR Part 35," Medical Use of Byproduct Material" 10 CFR Part 36," Licenses and Radiation Safety Requirements for Irrat stors" 10 CFR Part 39,"I icenses and Radiation Safety Requirements for Wc.i Logging" 10 CFR Part 40," Domestic Licensing of Source Material" 10 CFR Part 70," Domestic Licensing of Special Nuclear Material" 10 CFR Part 71," Packaging and Transportation of Radioactive Material" 10 CFR Part 170," Fees for Facilities, Materials, import and Export Licenses and Other Regulatory Services Under the Atomic Energy Act of1954, as Amended" 10 CFR Part 171," Annual Fees for Reactor Operating Li.enses, and Fuel Cycle Licenses and Materials Licenses, including lloiders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Govemment Agencies Licensed by NRC' To request copies of the above documents, call the Govemment Printing Oflice (GPO) order desk in Washington, DC at (202) 512-1800. Order the two volume bound version of Title 10, CFR, Parts 0 50 and 51-199 from the GPO, Superintendent af Documents, Post Oflice Box 371954, Pittsburgh, Pennsylvania 15250-7954. Single copies of the above documents may be requested from the NRCs Regional or Field Oflices (see Figure 2.1 for addresses and telephone numbers).

The regulations embodied in 10 CFR 30.32(g) and 32.210 codify the current and long-standing practice whereby vendors of scaled sources of radioactive material and devices containing scaled 4-1 NUREG-1556, Vol. 3 (draft)

sources submit radiation safety information necessary to perform an independent, technical safety evaluation, and to obtain registration of radiation safety information on certain scaled sources and devices. The practice has been used by the United States Atomic Energy Agency /NRC since the 1950 s and by the Agreement States staning in 1962.

The specific provisions in 10 CFR 30.32(g) require a license appbcant to either make reference to a registered sealed source or device or provide the infomiation necessary to perfomi a safety evaluation of the scaled source or device. Section 32.210 outimes the NRC safety evaluation and registration criteria and clarifies the regulatory responsibility of registration certificate holders of products for which the NRC evaluates and registers radiation safety information.

Current regulations only require that products used under a specific license issued in accordance with 10 CFR Part 30 be registered wit's the Commission. However, if registration of a product design is deemed necessary by NRC, the applicant needs to provide the information contained in 10 CFR 32.210 and the application will be evaluated in the same j

manner as all registration applications, The products listed in Sections 4.1 through 4.5 are used by pcisons exempt from heensmg requirements or used in accordance with a general license and NRC has determined that j

registration of the product design is necessary. Ilowever, in addition to the general registration criteria in 10 CFR 32.210, the regulations require that the products meet certain specific requirements. These specific requirements are listed in the appropriate section (Sections 4.1 through 4.5) and need to be addressed during the product evaluation.

Some specific-licensed products are required, by regulation, to meet certain specific requirements in addition to the general registration criteria provided in 10 CFR 32.210. The specific requirements for these products are listed in Sections 4.6 through 4.9 and need to be addressed during the product evaluation.

4.1 Self-luminous Products Containing Tritium, Krypton-85, or Promethium-147 for Use by Persons Exempt from Licensing Requirements Under 10 CFR 30.19, persons are exempted from licensing requirements if the products are initially transferred in accordance with a license issued pursuant to 10 CFR 32.22. Therefore, the requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

' NUREG-1556, Vol. 3 (drafi) 4-2

Area to be Addressed Applicable 10 CFR Reculations Design 30.19(a) & (c),32.22(a)

Maximum Radiation Levels 32.22(a)(2)(v/)

Maximum Dose Commitments 32.22(a)(2)(rlii)&(xiv) j Labeling 32.25(b)'

9&.

Figure 4.1 - Watches and Aiming Sights - Watches and aiming sights are products distributed to persons exempt from licensing under 10 CFR 30.19.

9MQT%,. -..

$g$$%

Ggtwe c

gy m;m 9 m ym t

g g s, m p g[J X e,..

' 1;g @ d '

wpm g}'pe4 y E

' fa

%pg^ys t

, qH m % gr.

n <

4 i

, wy mj ~ p y~

y jQ(9 O j.

' [g

)

p.,p+j j j h.33 '

f'[e t e

2l f,i h[U ? Id.jGP ih

, m, 1

Qy s

. y '.,w~;jlA w;,j

@l

]-

{;;f t M

M u.%

~

n t

4 3

~ t; y g

1 jf.r l

LJ

' ~.

e

-v n_:

Figure 4.2 - Smoke and Chemical Agent Detectors - Smoke and chemical agent detectors are products distributed to persons exempt from licensing under 10 CFR 30.20.

1

' The regulation requires identification of the person licensed under 10 CFR 32.22. Identification can be the 11111 name of the licensee, their registered trademark, or their NRCexempt distribution license number.

4-3 NUREG-1556, Vol. 3 (draft) l

4.2 Gas and Aerosol Detectors Containing Byproduct Material for Use by Persons Exempt from Licensing Requirements Under 10 CFR 30.20, persons are exempted from licensing requirements if the products are initially transferred in accordance with a license issued pursuant to 10 CFR 32.26. Therefore, the requirements for product evaluation are imposed on the person licensed to manufacture or initially transf,r the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

Area to be Addressed Apolicable 10 CFR Reculat ons i

Design 30.20(a),32.26'

'daximum Radiation Levels 32.26(b)(6)

Maximum Dose Commitments 32.26(b)(13)&(H)

Labeling 32.29(b)*

4.3 Devices Used under the General License in 10 CFR 31,5 Under 10 CFR 31.5, persons may use certain devices in accordance with a general license provided the devices were manufactured or initially transferred in accordance with a license issued pursuant to 10 CFR 32.51. The devices used under the general license ' include devices designed for the purpose of detecting, measuring. gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere. The requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

Area to be Addressed Applicable 10 CFR Reculations Design 31.S(a),32.51(a)(2)(1)

Maximum Dose Commitments 32.Sl(a)(2)(ii)&(iii)

LabeIing 32.5I(a)(3)

Leak Testing 32.5/(b)

Testing and Servicing 32.51(b) & (c)

' This regulation is applicable to devices designed to protect life or property from fires and airborne huards, it has been determined that gas and aerosol detectors designed to detect explosives or chemical agents may be licensed for distribution in accordance with this regulation.

• The regulation requires identification of the person licensed under 10 CFR 32.26. Identification can be the full name of the licensee, their registered trademark. or their NRC exempt distribution license number.

UUREG-1556, Vol. 3 (draf1) 4-4

l l

{

t 5 -

gggrA at T.

t.

a

(

%ggq,

d Q;;

Ly@d i d h r. n.~Ro,gl

=

~s iM Qb h.@a nGW g

gu ag

<g

& si sc:6 ;n.;g O'

.q 9

e W

m;3 m

kA h _

n2 a iA4 -

Figure 4.3 - 10 CFR 31.5 General License - Gas chromatographs, density gauges, and static elimination devices are products used under 10 CFR 31,5 general license.

4.4 Luminous Safety Devices Used in Aircraft under 10 CFR 31.7 Under 10 CFR 31.7, persons may use luminous safety devices containing tritium or promethium-147 in accordance with a general license provided the devices were manufactured or initially transferred in accordance with a license issued pursuant to 10 CFR 32.53. Therefore, the requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation, are listed below:

Area to be Addressed Applicable 10 CFR Reculations Design 32.53(c)&(d)

Prototype Testing 32.S3(d)(4),32.101 Labeling 32.54 Quality Control 32.55,32.110 4-5 NUREG-1556, Vol. 3 (draft)

• I

%. m :.

.x = _n, mb>

N $ fi [ 5 @ @ h j

. ~ '

h$b

$$NObdN Figure 4,4 10 CFR 31.7 General License - Safety devices, such as exit signs, containing tritium or promethium 147 and used in aircraft may be used under 10 CFR 31.7 general license.

4.5 Ice Detection Devices Containing Strontium-90 Under 10 CFR 31.10, persons may use ice detection devices containing strontium 90 in accordance with a general license provided the devices were manufactured or initially transferred in accordance with a license issued pursuant to 10 CFR 32.61. Therefore, the requirements for product evaluation are imposed on the person licensed to transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

Area to be Addressed Applicable 10 CFR Reculations Des'.gn 32.6I(c)&(e)

La% ling 32.6I(d)

Pr.uotypc Testing 32.61(e)(4),32.103 Quality Control 32.61(e)(5),32.62,32.110 4.6 Radiography Equipment Persons specific licensed to perform industrial radiographic operations are only authorized to use equipment that meets the requirements of 10 CFR Part 34. The vendor or custom user of the equipment may demonstrate that the equipment meets these requirements as part of the evaluation and registration of the equipment. Therefore, during an evaluation of radiography equipment, the items listed below must be addressed:

NUREG-1556, Vol. 5 (draft) 4-6 i

t Area to be Addressed Applicable 10 CFR Reculations i

Design.

34.20(a),34.22 -

Ixak Testing 34.27 Labeling 34.20 Prototype Testing 34.20 Maximum Radiation Levels 34.20,34.21 l

gg

-. c-u n

r-N

= =,,

/

L.:'2':2 N#

L._

Ngww.Cormed Figure 4.5 - Radiography Equipment - Radiography equipment, such as the equipment shown above, must meet the requirements of 10 CFR Part 34, 4.7 Well-Logging Equipment Persons specineally licensed to perform well-logging operations are only authorized to use equipment that meets the requirements of 10 CFR Part 39, Subpart C. One such requirement

= is that the licensed material be as insoluble and nondispersible as practicable. The vendor or custom user of the equipment may demonstrate that the equipment meets the requirements as part of the evaluation and registration of the equipment. Therefore, during an evaluation of well logging equipment, the items listed below must be addressed:

Area to be Addressed Anoticable 10 CFR Reculations.

Labeling 39.31(a)

Leak Testing 39.35 Design 39.41(a)(1) & (2)

. Prototype Testing 39.41(a)(3) 4-7 NUREG-1556, Vol. 3 (dran)

..g Q Figure 4.6 - Well-Logging Operations - Sealed o,...

jf sources used in well logging operations must meet the requirements of 10 CFR Part 39.

J 4.8 Irradiators Persons specifically licensed to use sealed sources in irradiators are only authorized to use realed sources that meet the requirements of 10 CFR 36.21. One such requirement is that the licensed material be as insoluble and nondispersible as practicable if used in a wet-source-storage or wet source-change irradiator. The vendor or custom user of the scaled sources may demonstrate that the scaled sources meet the requirements as part of the evaluation and registration of the sealed source. Therefore, during an evaluation of irradiator sources, the items listed below must be addressed:

Area to be Addressed Annlicable 10 CFR Reculations Design 36.21(a)(2), (3), & (4)

Leak Testing 36.59 Prototypc Testing 36.21(a)(5) na*=sm unum M'

[,

Room hg sun C"*

w to m s e... _.

(b)

Figure 4.7 - Irradiators - NRC evaluates both (a) category 1 (self-shielded) irradiators and, (b) scaled sources used in category IV (panoramic, wet source storage) irradiatois.

NUREG 1556, Vol. 3 (draf1) 4-8 l

4.9 Sealed Sources and Devices for Medical Use in accordance with 10 CFR 35.49, only sealed sources and devices that are manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to 10 CFR

- 32.74 may be used for medical uses. The vendor of the scaled sources may demonstrate that the scaled source meets the requirements as part of the evaluation and registration of the sealed source or device. Therefore, during an evaluation of medical scaled sources or devices,

'he items listed below must be addressed:

Area to be Addressed Annlicable 10 CFR Reculations Labeling 32.74(a)(2)(viii) & (a)(3)

Leak Testing 32.74(b)

One exception to the above requirement is teletherapy sources. Specifically, teletherapy sources do not need to meet the requirements of 10 CFR 32.74. Ilowever,10 CFR 35.49(b) indicates that they do need to be manufactured and distributed in accordance with a license issued pursuant to 10 CFR Part 30.

4-9 NUREG-1556, Vol. 3 (draft)

I

5 GENERAL POLICIES AND PROCEDURES 5.1 Sealed Source and Device Designs That Do Not Require Evaluation by IMNS 10 CFR 30.32(g) applies to all scaled sources and devices used by NRC specific licensees and requires evaluation of the product by NRC. Ilowever, the possession and use of certain products does not require the evaluation and registration of the product by 1MNS.

Specifically, evaluation and licensing of the following products should be handled as indicated below by the license reviewer:

5.1.1 Calibraiion and Reference Standards Calibration and reference sources may be licensed without evaluation review by 1MNS if the sources do not exceed the following:

For beta and/or gamma emitting material - 3.7 MBq (100 microcuries) or ten times the quantity specified in Section 50.71, Schedule B,10 CFR 30, whichever is greater.

For alpha emitting material - 0.37 MBq (10 microcuries).

The above values were chosen because they represent minimal hazard to public health and safety. To license these sources, license reviewers need to identify the isotope in item 6 of the license, use the statement " calibration or reference sources" in item 7, and state the maximum quantity for each source in item 8. Both possession and distribution to specific licensees may be authorized.

k Figure 5.1 - Calibration and Reference QJ#

may not need evaluation and registration by Sources - Calibration and reference sources IMNS.

e G

5-1 NUREG-1556, Vol. 3 (draft)

5.1.2 Products Used in Research and Development or by Broad Scope Licensees Scaled sources or devices containing scaled sources that are intended only for use under research and development or broad scope licenses need not be evaluated by IMNS if the licensing reviewer has made a determination that:

for unregistered sources, or registered sealed sources not possessed and used in accordance with the registration, - the licensee is qualified by sufficient training and experience and has sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unsealed form.

for registered scaled sources contained in unregistered devices - the licensee is qualified by sufficient training and experience and has sufficient facilities and equipment to safely use and handle the requested quantity o. radioactive material in unsealed form.

If a research and development or broad scope licensee wishes to transfer a scaled source or device to another specific licensee, then the recipient must meet the criteria listed above or the scaled source or device must be registered in accordance with 10 CFR 32.210 prior to transfer.

License reviewers should utilize the follcwing standard license condition for those recipients of the registered scaled source contained in unregistered devices:

"The licensee shall use only scaled sources for which a sealed source registration certificate has been issued by the U. S. Nuclear Regulatory Commission pursuant to 10 CFR 32.210(e) or an Agreement State. Possession and use of the scaled sources used must adhere to the conditions and limitations of the registration certificate."

5.1.3 Custom Scaled Sources or Devices Scaled sources or devices containing scaled sources built to the unique specifications of a given user (custom) need not be sent to IMNS for evaluation if: (a) they contain less than 7.4 GBq (200 millicuries) of radioactive material or less than 740 GBq (20 curies) of tritium, and (b) the licensing reviewer has made a determination that the applicant is qualified by training and experience and has adequate facilities and equipment to safely use and handle the requested quantity of radioactive material in unsealed form. Thus, the applicant would not have to rely on the intrinsic safety of the sealed source or device to demonstrate compliance with 10 CFR 30.33. Custom scaled source and devices which contain an activity greater than titat listed above must be submitted to IMNS for evaluation and registration.

To license these custom sealed sources and/or devices, license reviewers need to identify the isotope in item 6 of the license, use the statement " custom source"(for unregistered sources) or " scaled source"(for registered scaled sources) including a unique identifici (e.g., drawing or model number), if possible, in item 7, and state the maximum quantity of radionuclide per NUREG-1556. Vol. 3 (draft) 5-2

source or device in item 8. In Item 9 (authorized use) license reviewers need to describe, as clearly as possible, the actual use of the custom source or device. Examples: ' For use in a Model-A analyzer custom built for the licensee by ABC Company in Notown" or " Custom source for use in XYZ Model 100 gauge."

The authorization to use sources or devices deuribed above, that have not been evaluated and registered by IAfNS, apply to only to the custom user of the product.

5.2 Custom Users A user of a product that is manufactured in accordance with the unique specifications of, and for use by, a single applicant is considered a custom user. Custom users are specifically identified on the first page of registration certificates. The request for the safety evaluation and registration of the product r..ay be made by the custom user or vendor. Regardless of the applicant, the custom user is required to meet all conimitments made in the application and registration certificate. Typically, no more than two different NRC or Agreement State licensees may be custom users of, and may register, the same product. However, a custom user may acquire and/or use more than one product.

5,3 As Low As is Reasonably Achievable The Commission's requirements to establish programs, procedures, and engineering controls for achieving doses that are as low-as-is-reasonably-achievable (ALARA) are included in 10 CFR 20.1101. Regulatory Guide 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as is Reasonably Achievable," explains the NRC's position on this subject. Although these requirements apply to possession and use of radioactive material, applicants should consider the ALARA philosophy when desi;;ning and constructing sealed sources or devices to avoid unnecessary exposures during installation, maintenance, repair, and use of the scaled source or device. Regulatory Guide 8.10 may be useful to applicants for establishing and following an ALARA philosophy during the design of a sealed source or device.

5.4 Natural ly Occurring or Accelerator-Produced Radioactive Material Agreement and Non-Agreement States issue registration certificates for sealed sources or devices containing Naturally occurring or Acceleratc.-produced Radioactive Material (NARM). Copies of these registration certificates are 'rovided to IMNS by tne States. IMNS does not perform a review of these certificates, but does incorporate these certificates into the national registry. Copies are forwarded to the NRC regions, all Agreement States, and appropriate Federal and international agencies as a service to the States. This practice replaces the United States Food and Drug Administration (FDA) " Radioactive Materials Reference Manual." Questions concerning NARM certificates should be directed to OSP, the State, or FDA.

l L

5-3 NUREG-1556, Vol. 3 (draft) i l

As a general rule, the NRC does not accept applications for radiation safety evaluation and registration of sealed sources or devices that contain NARM. Exceptions to this general rule include sealed sources or devices that contain material that can be reactor or accelerator produced (e.g., cadmium-109), or sealed sources or devices that contain NARM commingled

- with byproduct material, in either the same or separate encapsulations (e.g., moisture density gauges containing radium 226 and cesium 137).

5.5 Foreign Vendors Foreign vendors present a unique situation for the NRC in that the NRC has no jurisdiction over foreign entities. The NRC has historically followed the regulation of 10 CFR Part 110 since a foreign vendor is required to establish an address in the United States to which the NRC can correspond and serve papers as recessary to accomplish its mission. In addition, the NRC inspects the United States distributor of the product and may occasionally audit foreign vendors to determine if the products distributed are in accordance with the statements made in support of the registration certificates.

V bg i

e Ik h y

f,W

$u,-

t o

h

• e k

'k, y

d Q.

Figure 5.2 - Map of the World - Foreign vendors are required to establish an address in the United States to which the NRC can correspond and serve papers as necessary to accomplish its mission.

5.6 Use cf International or Foreign Standards 1

In some cases, an applicant may wish to test a product in accordance with an international or foreign standard. In order for the NRC to find this acceptable, the applicant must first demonstrate and the reviewer confirm that the standard meets or exceeds any specific regulatory requirements (e.g., compliance with American National Standards Institute (ANSI)

N432-1980 for radiography equipment). The applicant and reviewer must each review the requirements and acceptance criteria of the standard based on the normal and likely accident conditions associated with use, handling, storage, and transport of the product to determine if the standard is acceptable. The foreign or international standard may be compared with an

- NUREG-1556, Vol. 3 (draft) 5-4

applicable United States standard in determining the acceptance of the standard. This may include professional judgement on the parts of the applicant and reviewer.

5.7FDA-NRC Memorandum of Understanding The FDA and the NRC signed a Memorandum of Understanding (MOU)' to coordinate existing FDA and NRC regulatory programs for medical devices, drugs, and biological

. products that make use of byproduct, source, or special nuclear materials, The principal-statute under which the FDA regulates devices is the Federal Food and Drug and Cosmetic Act, as amended by the Safe Medical Devices Amendments of 1976, the Safe Medical Devices Act of 1990, and the Medical Devices Act of 1992.

Under the MOU, the agencies agree to promptly infonn each other whenever they receive a report or otherwise become aware of any potential public health problems involving products of mutual regulatory concern. Further, the agencies will share information to the extent practicable. For IMNS, this includes information used by the NRC for product evaluations

- and approvals, and any incidents involving product failures. The FDA must be notified in writing when the NRC begins an evaluation of a medical product, whether it is for a new product or for' an amendment to an existing product. The notification should include the company, product model number, and the scope of the request. NRC policy precludes the approval of a medical scaled source or device unless the applicant has submitted a pre-marketing approval (510k) issued by FDA If the prc marketing approval is not submitted with the application, the applicant will be instructed to contact the FDA and obtain the appropriate approval.

Applicants needing information on FDA requirements may contact:

Food and Drug Administration Office of Compliance liFZ-300

- 2098 Gaither Road Rockville, MD 20850 (301) 594-4692 i

' The MOU was published in the Federal Recister (58 FR 47300) on September 8,1993.

5-5 NUREG-1556, Vol. 3 (draft)

5.8 Computer Software NRC safety evaluations concentrate only on those systems that control fundamental safety processes such as checking an interlock, source or shielding position, and the functionality of position indicators. Software applications that deal with process controls are not part of the product evaluation. The reviewer will determine that if such systems fail (e.g., a power failure), the scaled source or shielding would return to, or. amain in, the fully shielded position. Medical applications involving computer seitware and patient planning systems are, in general, within FDA jurisdiction and FDA is resronsible for any necessary review of the software.

,77w y,m7 4,3,,

P Figure 5.3 - Computer Software - Safety bhDN evaluations concentrate only on those systems that

.m3, b

control fundamental safety processes such as k.

a 'l checking an interlock, source or shielding position, y

'g 3

and the ftmetionality of position indhators.

) u %-

s 30 Applicants should note that some computer systems and software programs, including embedded microprocessors, currently in use, and some systems and programs being distributed, may experience problems as a rcsult of the turn of the new century. Applicants should evaluate the effects of the problems on the normal operation and the operation of the safety features of their equipment.

5.9 Registration Certificate Revocation if it is determined that a sealed source or device evaluated by the NRC may pose an undue hazard when used in accordance with the conditions of the registration certincate and corrective actions cannot be implemented or agreed upon between the registration certiGcate holder and the NRC, the NRC may modify or remove the registration certincate from the national registry and may issue orders modifying licenses to all persons licensed by the NRC to use the sealed source or device. IMNS will also notify OSP so that the Agreement States are made aware of the NRC actions concerning the scaled source or device.

5.10 Incidents incidents involving products evaluated and registered by the NRC are assessed to determine whether the integrity or adequacy of the product was compromised. The assessment involves a re-evaluation of the product to determine its integrity and adequacy, taking into account the causes of the incident. If it is determined that a generic product fault exists, the registration certi0cate holder will be notified and appropriate actiow, affecting both products currently in NUREG 1556, Vol. 3 (dratt) 5-6

l q

use and newly manufactured products, will be taken. -In addition, the'NRC will re-evaluate similar products to ensure they are not susceptible to the same type of faults.

Usually, incidents caused by. abnormal or unauthorized use of the product would be considered licensing issues and would not require a re-evaluation of the product.

Some information concerning incidents involving products evaluated by the NRC is kept on file by IMNS for use in performing future evaluations of the products involved and products similar to those involved. Ho vever, the Offee of Analysis and Evaluation of Operational Data is the NRC Of0cc responsible for compiling, tracking, and analyzing incidents and -

reports.

5.11 Proprietary Information Registration certificates and information contained in the background files for the registration certificates, such as applica: ions, may be made available to the public. Persons may request access to this information in accordance with 10 CFR 9.23, Proprietary information (i.e., information not to be disclosed to the public) should not be included in an application unless it is the only means to adequately describe the radiation safety properties of the product. If an application contains information marked as

" proprietary," " confidential," " restricted," or "is the express property of Company X," the reviewer needs to detennine whether the information is necessary to perform the safety evaluation. If the information is not necessary, it should be returned to the applicant.

If the information is necessary, the reviewer needs to ensure that the applicant has submitted a formal request, in accordance with 10 CFR 2.790, for withholding the information. The reviewer needs to evaluate the applicant's request for withholding against the requirements in 10 CFR 2.790 (Appendix B includes a checklist for requests for withholding information from public disclosure). If the request is denied. in whole or in part, the reviewer needs to-give the applicant the option of withdrawing the information or application. If the applicant

. decides not to withdraw the information or application, the reviewer needs to notify the applicant in writing that the request for withholding has been denied and that the reviewer will disregard any references concerning the proprietary status of the information.

Any part of the application that the reviewer has determined should be withheld from public disclosure should be handled in accordance with Management Directive 12.6, "NRC Sensitive Unclassified Infonnation Security Program and the applicant should be notified in writing that the NRC plans to honor the request. However, the notification needs to inform the applicant that the NRC may have cause to review the determination in the future, for'-

- example, if the scope of a Freedom of Information Act request includes the information. In all review situations, if the NRC needs additional information from the applicant or makes a determination adverse to the initial determination, the applicant will be notified in advance of any public disclosure.

5-7 NUREG-1556, Vol. 3 (drafl)

5.12 Transportation This document does not cover detailed requirements for the transportation of devices and sealed sources. The NRC's transportation requirements are contained in 10 CFR Part 71,

" Packaging and Transportation of Radioactive Material." 10 CFR Part 71 establishes (1) requirements for quality assurance, packaging, preparation for shipment, and transportation of licensed material and (2) procedures and standards for NRC approval c,f packaging and si.ipping procedures for fissile material and for a quantity of licensed material in excess of a

" Type A quantity"(i.e., exceeding A or A as defined in 10 CFR 71.4).

i 2

Althc, ugh an application for radiation safety evaluation of a scaled source or device as discussed in this document is not expected to include a detailed description of packaging and transportation proecdures to demonstrate compliance with 10 CFR Part 71, the applicant is expected to be familiar with the way those requirements apply to the scaled source or device and the action needed to ensure that transportation of the device is performed in accordance with applicable requirements.

Any vendor who has questions about the requirements for transportation may contact the appropriate NRC region or NRC's Transportation Safety and Inspection Branch, Spent Fuel Project Office, at (301) 415 8502 to obtain assistance.

Packaging Transportation Property %% blocked, braced, secuw, and away from the drtver V

I k

g' ;

(

y

,c

/

}

7 n

s e

'~

mu #

62 prn4 9268400b 072897 Figure 5.4 - Packaging and Transportation - Registration certificate holders must meet all NRC and DOT requirements for packaging and transporting sealed sources and devices.

NUREG 1556, Vol. 3 (draft) 5-8

Althougl(IMNS does not evaluate packaging or transportation requirements during sealed

~

source os device evaluations, IMNS doe's evaluate the effects the packaging or transportation :

has on normal use'and operation of the product as part of the evaluation.- Specifically,;IMNSl evaluates the effects of normal conditions experienced during transport (e.g., extreme -

temperatures, vibration) on the sealed source or device. Applicants'should consider these1 effects during the design of the' products and packaging for transport.

l 59

- NUREG-1556, Vol. 3 (draft)

4 i

6 HOW.TO FILE y

No specia! form is required for applications for sealed source or device evaluations, llowever, to i

facilitate the review process, applicants for a scaled source or device evaluation are encouraged l

to do the fo!!ovcing:

Ocneral/ Format:-

Be sure to review the applicable regulations and use the mo>,.: cent guidance, including

+

this document, in preparing an application.

Submit all documents, including all drawings if practicable, printed, on standard 8 1/2

+

inch '. I 1 inch paper. If submission oflarger documents is necessary, they should be folded to 81/2 inch x 11 inch.

All pages in an application should be numbered consecutively. If revisions are necessary aller an application has been submitted, revised or replacement pages should be submitted and should show the date of revision or :: vision number. Supplemental pages submitted for insertion should be indicated alphanumerically (e.g.,12a,12b, etc.).

Submit an original, signed application and one additional copy. Retain a copy of the your registration application for future reference.

l Applicants may include a copy of their submittal on 3.5 inch disk in Wordperfect format.

mtent:

Complete the " Summary Data" section of Appendix C," Application and Review

+

Checklist."

Attach the balance of the application to the " Summary Data" information. The order of the lofonnation in the application should conespond to the appropriate sub-section in

' Section 10.

Complete the " Checklist" included in Appendix C as a guide to determine whether all necessary infomiation has been provided.

The application sbould also include a drawing (s), tw larger than about 4 inch x 6 inch, that may be included in the registration certificate, and that provide an overall representation of the product and its safety features.

- When drawings, operating manuals, descriptive sales literature, or similar documents are submitted as part of an application, they should be identified clearly as being part of the application. This might be done by marking the materials individually and listing them 61 NUREG-1556, Vol. 3 (draft)-

f m.

a

= - = - -

+-,%

,--...y..,-..w

,w-,

be5

--.-...-e,--.,

--s,,

n.y,,

,-w.m,-,,[,,=w.r..,,,yo

.,,r-y r,

on a cover sheet for the application or listing them as enclosures to the letter that transmits the application.

Avoid submitting propriet ry infonnation unless it is absolutely necessary.

The application should include a clear, concise presentation of the information necessary for the evaluation, avoiding ambiguous and conflicting statements and wordy descriptions that do not contribute to a technical review.

Tenns included in the application should be used as they are defined in NRC regulations and national consensus standards, as applicable. All abbreviations and acronyms should be defined.

Engineering Drawings:

All drawings should have a drawing number, ievision number, company name, title, scale, and date. References to parts or other drawings should be clearly indicated.

If drawings have been reduced or enlarged, this snc,uld be clearly indicated.

+

All drawings should include one or several isometric projection diagrams showing components pertinent to radiation safety such as shielding material, shielding thickness, on off mechanism, on-ofTindicator, label location, assembly methods, source mounting and security, and dimensions, tolerances, and materials of construction.

Engineering drawings, must be in English. To faciFnte preparing an applicatica on a product manufactured outside the United States, the applicant may elect to write or otherwise aflix the English translation directly on an engineering drawing.

It may be advantageous to submit a product (without radioactive material) er a part of a product with an application. For example, a vendor of radiography equipment may elect to submit a

" pigtail" connector (used to join the source assembly to the drive cable) as a means of clarifying the related engineering drawings and operating instructions. Large pieces of equipment should not be submitted because of handling and storage limitations at the NRC omces.

All license applications will be available for review by the general public in the NRCs public document room. ifit is necessary to submit p oprietaiy information, follow the procedure in 10 CFR 2,790. See Section 5.10 of this NUREO for additional details.

Applications may be scanned or put through an optical character reader to convert them to electronic format. To assist with the conversion of the application to electronic media, applicants are icquested to follow these suggestions:

NUREG 1556, Vol. 3 (drall) 6-2

Submit printed or typewritten, not handwritten, text on smooth, crisp paper that will feed

+

easily into the scanner.

Choose typeface designs that are sans serif, such as Arial, llelvetica, Futura Univera; the text of this document is in a senf font called Times New Roman.

Choose 12 point or larger font sire.

Aveld stylized characters such as script, italic, etc.

lle sure the print is clear end sharp.

+

lie sure there is high contrast between the ink -nd paper (black ink on white paper is

+

hast).

i 63 NUREG 1556, Vol. 3 (draft)

f WHERE TO FILE Applicants located in states or territories subject to NACjurisdiction wishing to register a scaled source or device may file an application with the NAC by submitting the application to:

-i !nited Szste Nuclear Regulatory Commission l

l t -aled Source Safety Section Division ofindustrial and Medical Nuclear Safety -

, Washington, DC 20555 0001 l

1 Please note that the above address is different from that of the appropriate NAC region to which persons would apply for authority to possess and use radioactive material under a manufacturing and distribution license. -

i Thb above address cannot accept mail requiring the receiver's signature (e.g., expres mail).

l Mall requiring the receiver's signature should be sent to:

United States Nuclear Regulatory Commission l

Scaled Source Safety Section Division ofIndustrial and Medical Nuclear Safety i

Two White Flint Nonh 11545 Rockville Pike North flethesda, MD 50852 Applicants in locations subject to Agreement State jurisdiction wishing to apply for safety evaluation and registration of a scaled source or device should file the application with the

- appropriate Agreement State agency, not the NRC. See Section 2 for additional information concerning filing applications with Agreement States.

t I

-71 NUREO-1556, Vol. 3 (draft).

,.a

...u

._,_._.m

8 REGISTRATION FEES Nch application for which a fee is specified, including applications for new registration certificates and registration certificate amendments, must be accompanied by the appropriate fee.

Refer to 10 CFR 170.31 to detennine the amount of the fee. For applicants for scaled source and device evaluations, the appropriate fee categories are 9A,913,9C, and 9D. The registration certificate or amendment will not be issued until full payment of the fee has been received.'

Once the technical review process has begun, no fees will be refunded; application fees will be charged regardless of the NRCs disposition of an application or the withdrawal of an application.

Most FRC registration certificate holders are also subject to annual fees; refer to 10 CFR 171.16, Consult 10 CFR 171.11 for additional infonnation on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for registration certificate holders that may qualify as "small entitles."

Direct all questions about NRCs fees to the Omce of the Controller (DC) at the VRC headquartersin Rockville, Maryland,(301)415 7554. You may also callNRCs toll free number (800) 368 5642 and then ask for extension 415 7554.

• This guidance is in accordance with a memorandum from Ronald Ssroggins, Office of the Controller, to all Regional Administrators dated March 17,1994 (Appendix D).

81 NUREG 1356, Vol. 3 (drafi)

9 DOCUMENT FLOW 9.1 Application Receipt and Assignment to a Reviewer Requests for safety evaluations of scaled tources or devices usually are submitted by the applicant directly to IAINS. Ilowever, applications may be submitted to other NRC sections or Offices (e.g., as part of a licensing action) and forwarded to IMNS as a technical assistance request. For example, the NRC regions and other sections within IAINS may receive requests as I

part of a license request, or OC may receive a request to make a registration certificate inactive.

ne processing of the application is the same in all cases, NRC staff submitting technical assistance requests for scaled source and device evaluations to IMNS should use NRC Form S67," Request for a Scaled Source Device Evaluation." The requester needs to follow the instruction block at the tap of the form for specific detail on how and what to submit.

When IAINS receives an application, an acceptance review is perfonned to determine whether there is sullicient information to initiate a review. If there is sullicient information to initiate a review, the applicant is sent a letter acknowledging receipt of the application; if not, the entire package is retumed to the applicant for resubmission of a complete application.

Applications are logged into the sealed source and device action tracking system where they await assignment to a reviewer. Each action is assigned a unique tracking number. Assignment to a reviewer is determined on a first in basis. An application may be assigned a higher priority based on the dire need for the product to prowet public health and safety, the product providing a currently unavailable benefit to society, or commercial hardship that is likely to be experienced by the applicant if the evaluation process is delayed. Requests for higher priority should include adequatejustification.

While an application is awaiting assignment to a reviewer, a copy of the cover letter to the application and the NRC Form 567 is sent to the OC for verification that the appropriate application fees have been received. OC will retum NRC Form S67 to /AINS indicating whether the appropriate fees have been collected. IAINS may start an evaluation of a sealed source or device belbre fees are collected, however, a final approval cd the product will not be issued until the application fees are paid in full.

9.2 Reviewer's Responsibilities The reviewer is responsible for perfomiing the technical evaluation of the i roduct, ensuring the pmduct meets all applicable standards and regulations, corresponding with the applicant to obtain additional information, if necessary, generating the registration certificate, and ensuring the application is reviewed and signed by two persons ha"ing signature authority, in addition, 91 NUREG 1556, Vol. 3 (draft) m

~..

_ =

l the reviewer needs to identify any complex policy issues and bring them to management's attention, in rame cases, the adequacy of an element of the product design may not be readily evident. As a result, it may be necessary for the reviewer to exercise professional judgment regarding the adequacy and safety of the product design. Suchjudgment should be discussed with the applicant and included in a note from the reviewer to the registration file. A copy of the note to the registration file should be provided to the applicant.

Once the evaluation and registration are complete, the registration certificate, including cover letter to the applicant and technical assistance request response, if.pplicable, and all information used in suppon of the evaluation, are forwarded i3 the registration assistant for distribution and filing.

See Section 2 concerning the NRC review of Agreement State registration certificates.

9.3 Distribution of Completed Certificates The registration assistant processes distribution of all re,dstration certificates issued by the NRC and the Agreement States.

ARer the registration certificate is completed and the package is forwarded to the registration assistant, all correspondence between the NRCand the applicant is sent to the Document Control Desk (DCD). Copies of Agreement State cenificates also are fbrwarded to DCD. DCD ensures that the infbrmation is included in Nuclear Documents System and the Public Document Room.

The registration assistant distributes copics of all registration cenificates to the NRC regions, all Agreement States, other l'ederal agencies, and international agencies. The NRC file center ensures that original NRC registration certificates are maintained in the registration folders and that a master set of copies of the cenificates are maintained and easily accessible to 13fNS.

9,4 Inclusion in the Sealed Source and Device Computerized Registration System Once :ssued, the registration certificate is added to the scaled source and device computerized registration system. The infonnation included on the first page of the registration certificate is included in the system and certificate information can be located by searching on any item that is included in the first page of the certificate (see Section 12.2);

NURiiG 1556, Vol. 3 (drat))

92

~

9 10 CONTENTS OF THE APPLICATION AND THE REVIEW PROCESS Applicants requcsihig safety evaluations and persons who evaluate the adequacy of products must address the followit., items to verify suf0cient information is submitted and determine whether the design of the product is adequate for its proposed uses.

Applicants are encouraged to follow the instructions in Section 6 and use Appendix C as a guideline when submitting applications. Applicants should complete the " Summary Data"

- section of the appendix and use the " Checklist" to ensure that they have addressed all items listed in this section. The balance of the application should be attached to the copy of the appendix. Reviewers should use the checklist to verify the applicant has addressed all items listed in this section.

It shouls. oc noted that certain ret,ulations include specine requirements applicable to evaluation and registration of products. Section 4 lists these regulations and each regulation also is listed at the end of the applicable topic of this section. The regulatory requirements take precedence over the general guidance provided in this section. Applicants must ensure, and reviewers verify, that all regulatory requirements are met.

The checklist is not considered an all inclusive review document. It is designed to highlight important aspects of the application. Further detail and review of speeine areas of the applications may be necessary.

10.1 Summary Information Mmmfattur.er and Distrihulgi Applications must include the complete names and addresses of both the manufacturer and distributor of the product. The same person may be both the manufacturer and distributor.

llowever, if different, the distributor sh uld be the person applying for the evaluation. The distributor will be responsible for meeting the requirements associated with the registration, whether the information is supplied by the distributet or by the manufacturer on behalf of the distributor.

Otstom User Applications must indicate whether the product is intended for use by a custom user. The customer user needs to be identined by name and complete address. See Section 5.2 for additional information concerning custom users.

10-1 NUREG 1556, Vol. 3 (draft)

s A product specifically designed and constructed to the order of a single licensee may be considered a custom product. Since 'here is a single user of the product, the NRC can appropriately consider specific depr : aes from accepted standards from the poin. of view of compr.nsating qualifications or conditions of use for the particular licensee. Usuelly, these departures occur in the areas of prototype testing and quality control (GC) procedures.

Other Companies involved The application must include the name, complete mailing address, and function of all other companies involved in the manufacture and distribution of the product.

hiedel Number. Scaled Source or Device Troe. and Princioal Use Code The application must clearly state the model number designation for the product. This model number will be listed on the registration certificate for the product and may be listed on licenses of persons applying to use the product. The model number is used by the NRC and Agreement States to uniquely identify the product.

An applicant may request to have a model listed as a series. In order to have the model listed as a series, there should be similarities in the design and construction of the products.

Applicants should provide detailed engineering drawings of each basic source or device series containing overall dimensions, maximum and minimum dimensions, tolerances, materials of construction, and differences between models in the series.

The application needs to identify the scaled source or device type as used by the industry (e.g., level gauge, radiography device, self-shieloed irradiator, teletherapy unit, etc.) and the principal use code that most accurately describes the product. A listinti of principal use codes is included in Appendix E. This information assists applicents and reviewers in determining the applicable regulations, codes, and standards that affect registration of the product.

The application also needs to identify whether the device is intended to be used under a specific license, general license, either a specific or general license, or by persons exempt from licensing requirements, if applicable, the applicant and reviewer need to determine which general license or exemption applies for possession and use of the product.

Information needed to make this determination must be provided by the applicant. This is discussed further under Section 10.2, which discusses the conditions of use of the product.

Radionuqjides Used in the Product The applicant must identify all radionuclides that will be used in the product and include the maximum requested activity for each, including loading tolerance. The application must also include t!9 form of the byproduct material, including contaminates or impurities, if applicable.

It is not necese:y for applicants to provide information on contaminates or impurities that NUREG 1556, Vol. 3 (draft) 10 2

have little effect on the radiation levels from the scaled source or on how the scaled source will react under extreme environmental conditions.

For evaluations of devices, the applicant must identify whether the associated sealed source is currently registered if so, the model number designation and the manufacturer or distributor of the sealed source, as listed on the registration certificate for the scaled source, must be Identified.

If the scaled source is not currently registered, the sealed source must be registered separately or as part of the device. in either case, the applicant must submit sufricient information to register the scaled source and the reviewer must perform a complete evaluation of the sealed source. If the scaled source is registered as part of the device, the registration certificate for.

the device should note that the scaled source is not registered separately, is registered as part of the device, and is only approved for use*in the device.

Igak Test Freauency

~

-The applicant must provide the maximum time interval between leak tests to be performed on the product. Typica"y, products are required to be leak tested at intervals not to exceed 6 months. Leak test procedures must be capable of detecting the presence of 185 Bq (0.005 microcurie) of removable contamination.

Products containing only krypton 85, hydrogen-3 (tritium), radioactive gas, isotopes with half-lives of 30 days or less, beta or gamma emitting material of no more than 3.7 MBq (100 microcuries), or alpha emitting material of no more than 370 kBq (10 microcuries) are exempt from periodic leak testing requirements.110 wever, prior to initial distribution of the product, a leak test should be performed.

Devices nvy be approved with leak test intervals greater than 6 months if sufficient information is submitted to justify such a request. Current policy requires, for specific-or 1

general licensed products, the applicant to supply the information listed in 10 CFR 32.51(b) or 32.74(b)(1) for evaluation if a longer lesk test interval is requested.

The following regulations should be referenced for additional infonnation concerning leak testing:

Regulations Applicability 10 CFR J2.51(b)

Devices used under the 10 CFR 31.5 general license, l# CFR 34.27 Sources and devices designed for use in radiography operations.

10 CFR 39.35 Sources used in well logging operations.

10 CFR 36.59 Irradiator operations, 10 CFR 32.74(b)

Sources or devices for medical use.

10 3 NUREG-1556, Vol. 3 (draft) r

~

r I

t f,'pflication and Sienature of a Manacement Reoresentative Individuals acting in a private capacity are required to date and sign the application.

Otherwise, representanves of the corporation or legal entity filing the application should date l

and sign the application. Representatives signing an application must he authorized to make hinding commitments and to sign official documents on hahalf of the applicant.

As discussed previously in Section 3 " Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the regulatery requirements.

The Nf(C will return all unsigned appileations for proper signature.

lt is a criminal offense to make a willful false statement or representation on

+

applications or correspondence (18 U.S.C.1001).

When the application references commitments, those items become part of the licensing conditions and regulatory requirements.

10.2 Conditions of Use 4

The applicant must identify, and the reviewer evaluate, the intended use and users of the product and which standards, policies, and regulations are applicable. Applicable standards or regulations may specify prototype testing, labeling, design, maximum external radiation levels, maximum dose commitments, QC and quality assurance (GA), or leak testing requirements.

The intended use of the product should include descriptions of the types of users, the locations of use, the occasions when persons will be near the device and the frequency of these occasions, and the possibility that the device may be used as a component in other products.

The applicant and reviewer must also evaluate the likely environments to which the product will be subjected during normal use and likely accident conditions. Normal use and likely accident conditions should include those experienced during use, handling, storage, and transportation (extremes experienced during accident conditions during transportation need not be consideted). The applicant and reviewer need to evaluate whether the product will be subject to extreme conditions of corrosion, vibration, impact, puncture, compressive loads, explosion, flooding, poor air quality, excessive high or low temperatures, change in temperature (i.e., thermal cycling), and cycling of the on/off mechanism.

The applicant should provide the estimated working life of the product. The reviewer should evaluate the product's estimated working life to determine whether it is justified based on the infonnation submitted, inclusion of the working life of the product is important since registration certificates do not have expiration dates. Therefore, the working life provides an

. Indication of when servicing or re-evaluation of a product integrity may be necessary.

NURl!G 1556, Vol. 3 (drall) 10-4 5

w<-

ye y-,-

• y y-y, w-.i-i.e y'--

y y

y y

y-y, p.ww w

g e

,ywrw-

-1gigy-e r-w eryt-y, i

m 4

10.3 Construction of the Product Applicants need to describe construction aspects of the product including components of the product, materials of construction, dimensions, assembly methods, source containment and shleiding, and operation of the product and its safety features. This should include a brief written description and summary of the construction aspects as well as specific, detailed descriptive data such as engineering drawings and product specification sheets.

The brief written description and summary of the construction aspects should include the overall operation of the product, identification of primary components and safety features, type of installation including method of attachment to its mounting if installed in a fixed

- location and means of relocation if portable, the primary construction materials used for the product's structure at d integrity and for its safety features, accessibility of the radiation beam during use, the means of providing containment, security, and shielding of the radiation source including shutters or other movable shielding, location and operation of on/off or shicided/ exposed indicators, and identification of other design features that protect the product from abuse or tampering. In addition, the identification of the components of the product and safety features should include a description of each's purpose, function, and operation. An

- overall drawing of the product identifying primary components and safety features and indicating overall dimensions is useful as a complement to the written description of the product and for providing an understanding of the operation of the product.

Detailed design and construction data should be sufficient to allow the reviewer to fully understand the construction and operation of the product and its components and safety features and to evaluate the product's safety and integrity. This should include complete annotated engineering design and/or construction drawings of all safety critical components, specificution sheets, materials lists, and/or detailed written descriptions. In particular, mounting and integrity of the radioactive material or scaled source in the product must be described in detail. Drawings of safety critical parts and components should be fully dimensioned with tolerances, include identification of the safety critical parts, indicate the materials of construction or refer to a materials specification sheet or list, indicate fabrication end assembly methods, and include a drawing number and revision date or number. Parts critical to safety include those parts or components that provide primary containment, safety, and shielding of the radioactive material or scaled source. In addition, drawings and descriptions of non safety critical components and parts that contribute to safety and/or integrity of the product should be provided. These drawings should include sufficient descriptive information to determine how the components contribute to the safety and/or integrity of the product, how the component is integrated with other components of the product, and determine if the non safety critical components could degrade the effectiveness or usefulness of safety critical components.

All special design features that protect the product from abuse, control the hazard from direct or scattered radiation, and discourage unanthorized access to the source need to be adequat,1y described. In addition, accessibility of the radiation beam during use, including the size of 10-5 NUREG 1556, Vol. 3 (draft)

openings or air gaps that could allow any part of a human body to enter the radiation beam, and any protective measures, additional guards, or installation requirements designed to prevent accessibility of the radiation beam during use need to be addressed.

The reviewer must evaluate how the product is constructed and evaluate its integrity. The reviewer should be able to determine the construction of the product from the drawings and written description provided with the application. During the evaluation of product integrity, the reviewer needs to ensure the following:

The assembly methods (e.g., welds, bolts, screws), including size, materials, and

+

spacing, and materials of construction of the device are sufficient to withstand normal use and likely accident conditions. These include being subjected to corrosive environments, vibration, impact, puncture, compressive loads, explosion, flooding, excessive high or low temperatures, and drastic changes in temperature (i.e., thermal cycling), and cycling of the on/off mechanism.

If construction includes use of dissimilar materials, the materials are compatible and

+

corrosion is not likely to occur because of contact between the unlike mate:ials (e.g.,

corrosion is likely when you have direct contact between aluminum and steel, or depleted uranium and steel). In addition, the materials, vill not cause corrosive environments without direct contact (e.g., Teflon can break down when subjected to radiation and cause a corrosive environment for certain metals).

The materials of construction (e.g., adhesives, lubricants, and gaskets) will not be detrimentally affected by exposure to radiation or expected conditions of use.

The assembly methods would have no detrimental effects on the product during its fabrication (e.g., heat from welding a holder directly to the sealed source; securing the scaled source by tightening a screw or bolt against the wall of the sealed source).

The fixed shielding will not move nor easily become dislodged from the device.

The mounting of the scaled source is such that the sealed source will not unintentionally move during use nor become dislodged from the device, and the mounting sufficiently secures the scaled source against access by unauthorized users.

All moving parts have adequate spacing to ensure they will not bind during use. The tolerances of the spacing between the parts should be such that likely changes (e.g.,

from beading, temperature changes causing expansion or contraction, introduction of foreign materials) will not cause binding that may lead to unintentional exposure of the source.

The device can be locked in the closed condition (source fully shielded) and cannot be locked in the open condition, if applicable.

NURl!G 1$56, Vol. 3 (draf1) 10-6

l The device contains indicators that clearly identify whether the source shielding is in

~

the open or closed position. If colors are used to identify the open or closed conditions, red should be used for the open condition where exposure could occur and green should be used for the closed condition where the source is " safe" in the shielded position.

Sufficient safety interlocks, barriers, or guards are included to prevent access to the radiation beam and prevent exposures in excess of those specified in the regulations (the inclusion of barriers or guards should be included as reviewer notes to alert license reviewers).

If pneumatic or hydraulic systems are used, there are appropriate filtration, relief

+

valvet, and operating pressures.

The operation is designed to be fail safe, that is, loss of power or a failure in the

+

system would cause the shutter to return to, or remain in, the fully shielded position.

If applicable, tamper resistant hardware or assembly methods are used in the design of the device. Typically, this is required for devices used by general licensees and persons exempt from licensing.

If applicable, the device is hermetically scaled from forcign materials or moisture.

Scaled sources contain appropriate internal void spacing to ensure accurr.te leak testing results, if applicable. In addition, void spacing should allow for any thermal expansion of the materials.

Integrity of the product does not necessarily mean the product will perform its intended uses after being subjected to an eccident or unlikely use conditions. Ilowever, the product should still ensure the byproduct m.iterial is not dispersed, the source capsule remains within the protective source housing. and the shielding integrity is not compromised. Typically, an increase in radiation of greater than 20% constitutes a compromise of the shielding integrity.

Appendix F includes a listing of references that may be useful in determining the adequacy and integrity of the product design.

The following regulations should be referenced for additional information concerning product designs:

Regulations Applicability l

10 CFR 30.19(a)&(c)

Devices used under the 10 CFR 30.19 exemption.

10 CFR 32.22(a) 10-7 NUREG-1.156, Vol. 3 (draft)

=. -

Regulations Applicability 10 CFR 30.20(a),

Devices used under the 10 CFR 30.20 exemption.

10 CFR 32.26 10 CFR 31.5(a),

Devices used under the 10 CFR 31.5 general license.

10 CFR 32.51(a)(2) 10 CFR 32.53(c)&(d)

Devices used under the 10 CFR 31.7 general license.

10 CFR 32.61(c)&(c)

Devices used under the 10 CFR 31.10 general license.

10 CFR 34.20 & 34.22 Sources and dcvices designed for use in radiography operations.

10 CFR 39.41(a)(1)&(2)

Sources used in well logging operations.

10 CFR 36.21(a)(2)(3)&(4)

Sources used in irradiator operations, 10.4 Labeling Applicants must provide a description of the labeling of the product, including information contained on the label. materials of construction of the label. and how and where the label is attached. The labeling should be sufficiently durable to remain legible for the useful life of the product and, for devices, should be in a readily visible location. It is recommended that applicants provide samples or copies of the labels as part of the application.

The reviewer must verify that the application includes sufficient information concerning the labeling of the product, in addition to applicable regulatory requirements, applicants and reviewer:i should follow the guidelines outlined below for labeling of produ'/ts:

For Devices: Model Number, Serial Number, Isotope, Activity, Distributor's Name, Date of Assay, Trefoil Symbol, and the words " CAUTION - RADIOACTIVE MATERIAL.."' If applicable, the label should include a statement that it contains depleted uranium as shielding and include the total weight of the uranium, The label should also include limiting conditions of use or other information necessary for safe use of the product, such as servicing instructions. if applicable.

For Scaled Sources: Should contain the same information as included on a device, llowever, because of its size, all of the information may not fit. Therefore, it should contain as much of the information as possible with inclusion based on the imponance of the information. The applicant should provide a justification for which information will be included. Final approval of the information is left to the discretion of the

' The word danger may be used in lieu of the word caution.

o l'

.NUREG 1556, Vol. 3 (draft) 10-8 l

reviewer. Below is a listing, in no particular order, of the information, with a description of why the information may be important:

Trefoil Symbol and/or the Words " CAUTION RADIOACTIVE MATERIAL"

- This information is important if a source is found by a membei of the public since it alerts the person finding the source that it contains radioactive material.

The trefoil system is fairly well recognized. Therefore, for small sources where all the information may not fit, it is probably more imponant than the words

" CAUTION RADIDACTIVE MATERIAL."

Serial Number - The serial number can usually be traced back to determine the original activity, isotope, date of assay, and the last known user of the source.

The current activity can be calculated, given this information. Ilowever, to trace back to this information, either the vendor or the last person possessing the source must be known and be in business. The serial number may be important for sources that would be stored in large quantities. This would assist the licensee in maintaining accountability of each source.

Distributor's Name or Logo - This may be important in trying to locate additional information conecrning the source. Ilowever, if the serial number is not known or the distributor is no longer in business, this information may not be of much value.

Model Number -Jhc NRC incluc'es the scaled source model numbers in its scaled source and device computerized registration system. Therefore, the NRC could identify the distributor, possible icotopes, and maximum allowable activities, given the model number.

l Isotope, Activity, Date of Assay - This information could assist trained personnel in responding to an incident involving the source, llowever, this information could be obtained from other information included on the source, as indicated above, or by analysis and from surveying radiation levels around the source.

The reviewer must evaluate whether the labeling is durable, will remain on the product, and will temain legible under normal use conditions through the working life of the product.

The preferred method of labeling scaled sources is engraving or laser etching the information.

For devices, the preferred method is a metal label, with the information engraved or etched into the label, and the label attached to the device with screws or rivets. Other materials and methods may be acceptable depending on the likely environments in which the product will be used.

10 9 NUREG 1556, Vol. 3 (draf1)

--e a

i b

Labels must be placed so that they are casily visible to the users of a device and will remam attached to the part of the device that contains the radioactive material, that is, they are not attached to the detector housing or to a barrier or guard. The applicant may elect to have additional labels on the detector housing or on barriers or guards.

The reviewer needs to verify that the labeling does not misinterpret, misrepresent, or lead the user into violating any applicable regulations. For example, devices distributed to specific licensees must not include statements concerning use of the device under a general license.

The following regulations should be reviewed for additional information concerning pmduct.

labeling:

Regulations Applicability 10 CFR 32.25(h)

Dcvices used under the 10 CFR 30.19 exemption.

10 CFR 32.29(b)

Devices used under the 10 CFR 30.20 exemption.

10 CFR 32.51(a)(3)

Devices used under the 10 CFR 31.5 general license.

10 CFR 32.54 Devices used under the 10 CFR 31.7 general license.

10 CFR J2.6/(d)

Devices used under the 10 CFR 31.10 general license.

l 10 CFR 34.20 Source and devices designed for use in radiography operations.

10 CFR 39.31(a)

Sources used in well logging operations.

10 CFR 32.74(a)(2)(riii)

Sourecs and devices for medical use.

& (a)(3) 10.5 Prototype Testing An applicant must provide information that verifies that the product design will maintain its integrity when subjected to conditions of normal use and likely accident conditions. Normal use and likely accident conditions should include those experienced during installation, use, handling maintenance, storage, and transportation (only normal conditions during transportation need to be considered). Applicants need to determine an appropriate method to demonstrate the product's ability to maintain its integrity when subjected to conditions of normal use and likely accident conditions. This may include:

- (1) Testing a protetype of the product, A prototype product must be a complete representation of the final product that includes all safety features shielding, safety markings (.if appropriate), and any accessory features or mounting that may have a detrimental effect to the safety and integrity of the product when subjected to normal or likely accident conditions, prototypes must be constructed from the sarne materials NUREG 1556, Vol. 3 (draft) 10 10

i l

and to the same dimensions and tolerances as the final product, but may be a scale representation of the final product. Any variations of the prototype product from the final product must be analyzed for the effect to the test results the change would be expected to cause (see engineering analysis below).

(2) Perfbrming an engineering analysis. An engineering analysis consists of a detailed, systematic analysis of the design and materials of construction of the product and the processes used in the manufacturing of the product to determine the product's ability to maintain its integrity when subjected to normal and likely accident conditions. The analysis may consist of calculations, modeling, sample testing, and evaluation. In addition, when evaluating products for which an industry standard is applicable, an engineering analysis may be used to demonstrate that the item would successfully pass the standard tests, if it were subjected to the tests. The conclusions of an engineering analysis should be fully justified with supporting documentation describing the analysis and including calculations or other applicable reference material.

(3) Operational history of the product. Operational history includes identical devices (excluding accessory equipment that has no effect on the safety or integrity of the product) used in equivalent or more severe conditions of normal use. This typically includes products used in the United States as a custom product or in another country.

Operational history should include tre environmental and operating conditions, numbers of cycles per year, the results of any known accident conditions, the results and root causes of any known product failures, and the years of use of the product.

Operational history must be sufficient to demonstrate that the product would be expected to operate safely and maintain its integrity during the product's intended normal conditions of use. In addition, if operational history is sufficiently comprehensive, it may also be used to demonstrate product integrity for likely accident conditions, llowever, a product's operational history would not be sufficient to demonstrate its ability to operate safely or maintain its integrity ifit has never been subjected to the extremes of expected normal use or likely accident conditions.

(4) Comparison to a similar or equivalent model previously reviewed and registered.

Information concerning a similar or equivalent product may be used to demonstrate 4

safety or integrity of the requested product, if the design of the similar or equivalent product and its intended normal and likely accident conditions of use are identical or similar to the requested product or can be related (through engineering analysis) to the requested product's conditions of use. in addition, prototype testing of the similar product may also be submitted ifit can be related to the requested product. The comparison should contain the information on the similar or equivalent product including prototype testing, applicable engineering analyses, or operational history and a detailed discussion and analysis of how this information relates to the requested product. In addition, the comparison must demonstrate that the requested product's ability to operate safely and maintain its integrity is equivalent to or more robust than 10 11 NUREG 1556, Vol. 3 (draf1)

i the previously. approved product, or that the differences between the products are such that the integrity and safety would not be affected.

Itegardless of which approach the applicant chooses to pursue, the reviewer must evaluate whether the applicant has adequately demonstrated that the product will maintain its integrity during normal use and likely accident conditions, and whether the information adequately addresses all concerns about the source or device's integrity when used in a way the applicant has defined as the normal conditions of use.

If the product is registered for use by a custom user, prototype testing may not be required.

This is typical in a situation where only a limited number of units will be manufactured, usually one or two. Therefore, it may not be feasible to manufacture and test a prototype product which may not be able to be used after testing. Since only one licensee is using the product, additional administrative controls can be implemented by the licensee.

SomEn Typically, for scaled sources, the NRC will only accept actual testing of a prototype unit to demonstrate integrity. This is because the scaled source is the primary containment of the radioactive material. The scaled sources should normally be tested in accordance with ANSI N542, " Sealed Itadioactive Sources, Classification," or International Organization of Standardization (ISO) 2919. " Sealed Itadioactive Sources, Classification." When reviewing the testing, the reviewer must evaluate the test methods, procedures, and conditions of the tests and acceptance criteria used by the applicant against the standard. Any variations must be evaluated.

In addition to testing in accordant. with an ANSI or ISO standard, the applicant may need to perform additional testing to verify that the source will withstand the conditions of use. l'or example, long sources may need to be subjected to a bend test and applicants may need to verify a source design will withstand corrosive environments.

Depending on the wall thickness of a source, engraving or etching the labeling information may have a detrimental effect on the source integrity. l'or thin walled sources, the prototype source should include all engraved or etched labeling information prior to testing.

Devices When evaluating a device, the reviewer must verify that the sealed source incorporated in the device has achieved the appropriate ANSI N542 or ISO 2919 classification for its intended use and be authorized for the activity to be loaded. The registration certificate for the scaled source should include its classi0 cation.

NURl!G 1556, Vol. 3 (drafi) 10-12

t Devices should be tested in accordance with applicable industry and consensus standards. A i

listing of applicable standards is included in Appendix G'.

If there is no applicable standard for a product, the applicant and reviewer, using professional judgement, need to ensure that the testing performed sufficiently simulates the conditions that may be expected during use,

- handling, storage, and transport of the product. The applicant and reviewer mt.y obtain useful general guidance from a standard for a comparable source or device.

In addition to tite testing recommended in the standards, the applicant and reviewer need to consider other potential use and accident conditions that may affect a particular device's integrity. Devices should be tested to demonstrate they will maintain their containment

~

integrity and that the necessary safety features remain operable after being subjected to any conditions they are likely to' experience.

i

'the testing does not need to verify that a device will operate and perform its intended function after being subjected to accident condition testing, llowever, the product should still ensure the byproduct material is not dispersed, the sourc: capsule remains within the protective source housing, and the shielding integrity is not compromised. Typically, an ixtease in radiation of greater than 20'4 constitutes a compromise of the shielding integrity.

Occasionally, an applicant may indicate that a product has been tested in accordance with a standard that has limited applicability in demonstrating that the product will perform adequately, from a radiological standpoint, during normal use and likely accident conditions.

Some examples of such standards are Type 7A package testing, special form testing for scaled sources, and testing to Underwriters Laboratory standards. The reviewer should ensure that '

the applicant does not rely on this testing alone to demonstrate device integrity.

The following regulations should be refercnced for additional infonnation concerning i

prototype testing:

Regulationn Applicability 10 CFR 32.53(d)(4),

Devices used under the 10 CFR 31.7 general license, c

10 CFR 32.101 10 CFR 32.6/(c)(4),

Devices used under the 10 CFR 31.10 general license.

10 CFR 32.103 10 CFR 34.20 Source and devices designed for use in radiography operations.

' For copies of standards, contact the licahh Physics Society,1313 Dolley Madison Blvd. Suite 402, McLean, VA 22101.

10-13' NUREO 1556, Vol. 3 (draft)

+

..e,-

-.w-

.~

,,,-------,e---e

-m.-

s,

,-e

~v,-

-~

a.n---

sven

t 10 CFR 39.41(a)(3)

Sources used in well logging operations.

10 CFR 36.21(a)(5)

Sources used in irradiator operations.

10.6 Radiation Profiles l

The applicant should provide the maximum radiation levels around the product when it contains the maximum allowable quantity of each nuclide, or combination of nuclides. The 1

applicant should include the maximum radiation levels on the surface of the product, at 5,30, and 100 cm (2.0,11.8, and 39.4 in.) from the product, and levels in the radiation beam (if the heam is accessible), if applicable, radiation levels should include when the device is in the open and closed conditions and when material is present in the measuring area. Doses during transient conditions and during other conditions of use, such as during calibration, may also need to be reported. The reviewer must verify that the applicant has provided the maximum radiation levels.

y - -

~.,

- -.., ' n e ' m..,,.

=d s

's

/

_,,,,, _,/

/,. - s g

(-

1. '* g g

,4-_

f I

g@ l--J~l l

1 --~~c--.g r i,i/

ii i

i g ' Q '[ (b,L-.

,.. j" l i

l I

i 0-

)

l

{ -.,

.._4

s. _

s s___.

\\

'if.: US*;l" T."JW f

\\

/

N A

N__'

t-_'

Figure 10.1 - Radletion Profiles - ANSI 538 suggest radiation profiles be.4 ovided as indicated above.

Measured radiation levels are preferable, but calculated levels also are acceptable. If the measured radiation levels are submitted, the reviewer needs to verify that the conditions under which the measurements were taken and the equipment used -- including type, window thickness, and sensitivity -- are acceptable for the nuclide and quantity included in the ~

product. If calculated levels are st tmitted, the reviewer needs to verify the calculations were performed in accordance with acceptable methods or standards.

NUREG-1556, Vol. 3 (draft) -

10 14

If the applicant is taking credit for external shielding or barriers or guards that restrict access to higher radiation areas, the radiation levels at, and at distances from, each barrier or guard need to be reported.

The reviewer needs to verify tlut radiation levels are reasonable. The levels for gamma emitters should be consistent with the inverse-square law and levels for non-gamma emitters should not. The reviewer also needs to assess whether levels that initially appear unreasonable, such as higher levels farther from the product, are possible because of scatter.

Even though 50 pSv/hr (5 mrem /hr) at 30.5 cm (12 in.) is an industry goal that has been used for many years, in general, there are no maximum external radiation level limitations for scaled sources and specifically licensed devices. Ultimately, it is the responsibility of the user to ensure the product is used in accordance with 10 CFR Part 20, (e.g., the specific licensee is responsible for ensuring that persons do not receive doses in excess of the occupational limits or limits for members of the public and that occupational exposures are AIARA).

If a device is intended for use on a patient, the dose to the patient for a typical application should be provided. This will serve as a reference point in approving and licensing the product.

The following regulations should be referenced for additional information concerning radiation profiles and maximum dose commitments:

Regulations Applicability 10 CFR 32.22(a)(2)(vi),

Devices used under the 10 CFR 30.19 exemption.

(xill), and (xlv) 10 CFR 32.26(h)(6),

Devices used under the 10 CFR 30.20 exemption.

(13), and (14) 10 CFR 32.51(a)(2)(ll)

Devices used under the 10 CFR 31.5 general license.

&(iii) 1

~

10 CFR 34.20 & 34.21(a)

Source and devices designed for use in radiography operations.

10.7 Quality Control and Quality Assurance The applicant must provide details of the GC program that will be implemented to ensure that the product la manufactured and distributed in accordance with the representations made in the application, and the statements contained in the registration certificate for the product. At a minimum, the GC program needs to ensure that: (1) the materials of construction and the final ossembly meet the design specifications; (2) the final product is leak tested; (3) a final radiation profile is p:rfonned; (4) a test that verifies the product operates as intended, L

10-15 NUREG-1556, Vol. 3 (drafi) 1

i including all safety functions, is performed; and, (5) a visual and mechanical inspection of components that are considered critical to safety or are expected to be susceptible to failure under extreme or unusual conditions must be performed. Some of these inspections may be performed on a sample basis. The reviewer must verify that the applicant has provided adequate information concerning the GC program.

i i

Current practice allows acceptance of the submission of a GA program in lieu of a GC program. 'Ihe G4 program provides control over all activities applicable to the design, fabrication, inspection, testing, maintenance, repair, modification, and distribution of the scaled sources or devices. This puts more emphasis on the overall management structure and on the program that covers construction of the device from the time of initial design through refurbishment. Regulatory Guide 6.9," Establishing Quality Assurance Programs for the Manuliicture and Distribution of Scaled Sources and Devices Containing 11yproduct Material,"

provides applicants with infbrmation necessary to establish and implement a GA program that encompasses all of the GA and GC requirements necessary for the manufacture and distribution of scaled sources and devices. The guide contains sample documentation and a checklist ihr assessing completeness and implementation of the program. GA programs submitted by applicants are evaluated against Regulatory Guide 6.9. It should be noted that Regulatory Guide 6.9 discusses acceptance of programs meeting the requirements of other established GA standards.

If the product is registered for use by a custom user, submission of a complete GC program may not be required. This is typical in a situation where only a limited number of units will be manufactured, usually one or two. Since the purpose of a GC program is to ensure all devices are manufactured to the same specifications, development and submission of a complete program may not be feasible. Since only one licensee is using the product, additional administrative controls can be implemented by the licenn The following regulations should be referenced for additional information concerning quality assurance and control:

Reg 5ations Appliemhility 10 CFR 32.55 & J2.110 Devices used under the 10 CFR 31,7 general license.

10 CFR 32.61(e)(5), 32.62, Devices used under the 10 CFR 31.10 general license.

& 32.110 10.8 Installation, Servicing, and Instructions to Users The applicant should provide any special procedures that need to be followed when the product is installed at the user's theility. These include verifying the integrity of the mounting, the installation of interlocks, guards or barriers, and determining whether the NUREG 1556, Vol. 3 (draft) 10-16

l installation needs to be performed by a specinc licensee. General licensees may be permitted to perform installation depending on the design of the product.

In addition, the applicant needs to indicate whether other services necessary to support safe use of the products need to be performed by a specine licensee or may be performed by a general licensee. These include calibration, relocation, leak test, routine maintenance, radiation surveys, necessary training for users, changing of sources, and Gnal disposal of the byproduct material. The applicant needs to indicate whether the applicant, or the i

manufacturer or d:stributor, will provide the necessary services or identify an entity that will provide such services. If the applicant cannot identify an entity that will provide the necessary services, the registration certincate should include this in a reviewer note.

Ilowever, if the device is to be possessed and used by a general licensee, and the applicant cannot identify an ertity that will provide services that cannot be performed by the general-licensed users, the device should not be registered. Reviewers should recognize that vendors or service companies may discontinue providing services. The NRC is typically notined when a vendor decides to no longer provide services.

Registration certificate holders requesting to transfer a registration certincate to inactive status should identify whether they plan to continue to provide services for the registered products or whether they are aware of an entity that will provide services. See Section 13.3," Transfers to inactive Status" The reviewer needs to verify that procedures for servicing the product are adequate, can be performed by the persons indicated by the applicant t'e.g., by a general licensee), and do not interfere with, or compromise, the integrity of the product.

The reviewer must verify that the distributor provides the user of the product with the infor..iation necessary to safely operate and maintain the product. These include instructions for operation, maintenance, calibration, damage / failure, specine warnings, leak tests, and radiation surveys. The distributor should also provide information to the user concerning who may provide services for the pre V

t. For devices distributed to general licensees, the distributor needs to provide copw. of regulations governing use and transportation of the product and a listing of regulatory authorities who license possession and use of the product.

To assist the reviewer in detennining whether certain activities may be performed by general licensees, the applicant must provide an estimate of the dose to a worker for each activity to be perfonned.

The reviewer needs to verify that the documentation provided to users of the products does not misinterpret, misrepresent, or lead the user into violating any applicable regulations.

10 17 NUREO 1556, Vol. 3 (draft)

(

l

/l C Y r

rc 1

i r

d

(

u 1 1 w

gi

/gI N

ef a-

\\

)%

y Leak Testing Mounting Senvicing 62-pl4f268401c 080597 Figure 10.2 Installation and Servicing of Devices - Applicants must specify the qualifications needed by individuals to perform installation and servicing of devices.

The following regulations should be referenced for additional information concerning servicing:

Regulations Applicability 10 CFR J2.51(b) & (c)

Devices used under the 10 CFR 31.5 general license 10.9 Final Evaluation and Concurrence Once the reviewer has evaluated all necessary information and has determined that the product is acceptable for licensing purposes, the information will be passed to a second reviewer ;o perform an independent technical evahiation. The second reviewer must independently arrive at the same finding as the initial reviewer. Any discrepancies betweet, reviewers must be resolved before the registration certificate can be issued. Once both reviewers concur in the findings in the document, they will sign the certificate.

Typically, the initial reviewer will generate a draft registration certificate F.,r evaluation by the second reviewer, The second reviewer will evaluate both the applicatica and the draft registration certificate to ensure accuracy and completeness.

NUREG 1556, Vol. 3 (draft) 10 18

11 DEFICIENCIES IN THE APPLICATION in the process of evaluating an application, a reviewer may determ!ne that insufficient information has been submitted, if this is the case, the reviewer must contact the applicant to obtain the information. Depending on the type ofinformation needed, the reviewer may obtain the information by sending a fonnal written request to the applicant, requesting a meeting with applicant, notifyinp the applicant of the need for infonnation via telephone or electronic mail, or obtaining the inform tion directly from the applicant during a telephone conversation or via electronic mail.

~

Because of the need to complete the application reviews in a timely manner, the reviewer should do the following when addressing deficiencies in applications:

11.1 Sending Deficiency Letters to Applicants Any significant or complex deficiencies in an application for an evaluation must be set forth in a fonnal deficiency letter to the applicant. The letter should request that the response be provided in duplicate. The letter to the applicant should request that the applicant respond within a specilled number of days from the date of the deficiency letter. The number of days is typically 30 to 60 days but depends on the complexity of the infonnation and the level of effort needed by the applicant to respond (e.g., extra time may be needed to perfomi prototype testing on a product).

If a written respense' to the deficiency letter is received within 5 working days after the date requested in the deficiency letter, the reviewer will proceed with review of the response, if a written response to the deficiency letter is not received within 5 working days after the date requested in the deficiency letter, the reviewer should send a second letter to applicant. The second lett,;r should notify the applicant that unless a response to the first letter is received within 30 calendar days from the date of the second letter, the reviewer will consider the application as " abandoned"* for failure to provide the requested information "without prejudice" to the resubmission of a complete application. Prompt action (5 working days) should be taken to " void" the application aller the application has been considered as " abandoned." The application will be held in a " void file "

• A written response may be either a letter or a fax from the applicant.

• " Abandoned" is not meant to have legal connotations. It means simply that the applicant for a new Ucense or for an amendment to an existing license has given up its pursuit of the license or amendment.

"Without prejudice" is not meant to be uMerstood in a legal sense. His means that the applicant can resurrect its application within some reasonable time without having to pay another fee, having its application redocketed, etc. " Void" should not be thought ofin its legal sense, it means here that the application is, in practical efTect, nullified.

Il-1 NUREG 1556, Vol. 3 (draft) l

If a response to the deficiency letter is received after the application has been voided and the response is received not more than 1 year from the date of the letter, the application should be assigned a new tracking number and handled as a new application. Ilowever, no additional fee may be necessary ifit is a continuation of the evaluation. liigher priority will not be assigned solely based on the fact the application is a resubmission.

11.2 Meetings with Applicants NRC or applicants may request meetings to discuss scaled source and device applications. The meetings may be prior to submission of an application or to discuss items included in a deficiency !ctter. Meetings between NRC and applicants may be at an NRC office, or at the applicant's facility ifit is determined that it would enhance NRC's understanding of the product.

11,3 Use of the Telephone or Electronic Vall to Obtain Additional Information There is no prohibition on using the telephone or electronic mail for obtaining clarifying information from an applicant. These mechanisms may be used to notify an applicant of simple deficiencies, to accelerate the review process.

Use of the telephone or electronic mail for notifying an applicant of deficiencies must be limited to items that are simple and such that they can be specified simply. Simple items include a model number for a scaled source, need for a applicant commitment to perform a procedure, or clarification of a material type or a dimension.

If the deficiency is a clarification ofinformation provided in the application, it may not be necessary to have the applicant respond in writing. This decision is left to the 6scretion of the reviewer. Ilowever, the applicant's response, either via telephone or electronic mail, must be documented and included as part of the application, in all cases, the telephone conversation or electronic mail transmitting deficiencies to an appliemd must be documented by the person initiating the telephone call. If the applicant does not respond within 15 calendar days, a confinnatory letter must be sent to the applicant. The confinnatory letter must clearly specify the deficiencies and be handled as a typical deficiency letter with the exception that it includes a statement that the infonnation needs to be received within a specified time frame or the application will be voided.

11.4 Response Time Extensions A request from an applicant for an extension of time to respond to any correspondence about its application may be granted ifit is determined that there is good cause to grant an extension. The request may be in writing or via the telephone. Typically, the reviewer responds by telephone to notify the applicant that an extension has been granted. All requests for extensions must be approved by Manageme 1t and must be documented in a conversation record.

NUREG-1556, Vol. 3 (draf1) 11-2

-r--

-e e

12 CONTENTS OF THE CERTIFICATE Registration cenificates are written in a standard format. This allows license re hwers and inspectors to quickly retrieve information necessary to perform a license review, perform a site inspection, or respond to incidents involving lost, damaged, and/or abandoned scaled sources or devices.

The registration certificate is a summary of the technical evaluation of the product. It contains summaries of the areas examined during the eva ation process. Appendix 11 includes standard fonnats for registration certificates for a sealed sotr't, lor a device, and for an exempt device.

Funher clarification of the information that is inclu. A in a registration certificate is listed below.

12.1 Header The header includes the title of the document, the registration number, date ofissuance, page numbering, and the scaled source or device type, if the certificate is amended or corrected, this is indicated in the title; the page number of each corrected page(s) needs to be listed or the header notes that the cenificate is amended in its er.tirety. The registration number is assigned by the reviewer,in accordance with the numbering procedures in Appendix 1. The issue date is the date the cenificate has received both reviewer and concurrence signatures.

12,2 First Page information The first page of each certificate includes the name and complete address of the manu acturer r

and distributor, the model number of the scaled source or device, the manufacturer or distributor and model number for the sealed source incorporated in the device, isotopes, maximum allowabic activity levels, leak test frequency, principal uses (including code and description),

and an indication of whether the registered product is designed for custom use. If registered for custom use, the name and address of the custom user is included. This infonnation is entered into the NRC maintained computerized registry of scaled sources and devices.

The following subsections are included in the order listed below staning on the second page of the cenificate.

12,3 Description his section provides a narrative description of the construction of the product, safety features of the product, and ON/0FF and safety indicators. The description should include the materials of construction and fabrication techniques for critical safety components of the product. These typically include source encapsulation materials, source holder materials, shutter mechanisms, welding process, and device security features, such as tamper resistant fasteners, locks, etc.

Overall dimensions of the sealed source and the device are also included.

12 1 NOREO-1556, Vol. 3 (draft)

-~

l l

Certi0 cates for sealed sources ine!ude the chemical and physical forms of the source ma,erial.

Certificates for devices describe how the sealed source is secured within the device and how the product is protected from its intended environment (e.g., hermetically sealed, fire-proof, corrosion resistant, etc.).

12.4 Labeling This section describes how the labeling reqairements are fulfilled. It lists the information that can be found on the label, construction of the label, and how and where the labeling is attached to the product. Any exemptions from labeling requirements or omissions ofinformation typically included on the labels will be noted.

12,5 Diagrams This section lists the diagrams, drawings, sketches, or pictures of the product that are included in the certificate. These are typically included as attachmen'.s to the certificate and should include overall dimensions of the product, the location of the scaled source within the device, and the safety related features of the product. A person using the certificate, such as an inspector or license reviewer, should be able to identify a device given the diagrams and the descr:ption from the certificate.

12.6 Conditions of Normal Use This secdon lists the environmental conditions the product is intended to withstand. The normal intended uses of the product and any limitations that define these uses are included in this section. The v>orking life is also included.

12.7 Prototype Testing This section describes tests perfomied on prototypes of the product to demonstrate it will maintain its integrity, if the product was tested in accordance with an applicable industry or consensus standard, the corresponding classification, as defined by the standard, should be stated in this section. If the product was tested in accordance with an applicable regulation, this section specifies whether the product satisfactorily met the requirements of the regulation.

If, in lieu of prototype testing a product, an applicant submnted operational history of the product or a s.milar product or provided an engineering analyais that demonstrates that the product is adequately designed, this section will provide the details of the operational history or analysis arid the basis for determining the design to be adequate.

NUREG-1556, Vol. 3 (draft) 12-2 I

l 12.8 External Radiation Levels This section states the maximum radiation levels from the product when loaded with the maximum activity of each i.aclide or combination of nuclides. If the manufacturer is unable to provide measured extemal radiation levels for the product, a conservatively calculated maximum radiation profile is listed, if applicable, the radiation profiles are listed for shutter open and closed conditions. The stated levels are the maximum radiation levels expected from the product and take into consideration factors afTecting the levu, such as whether product is present in the measuring area or whether certain are;s around the device are restricted from access. Any significant contam,nants that would change the expected radiation levels are stated. Ideally, the radiation levels listed in this section will include the levels on contact with the product, at 5,30, and 100 cm (2.0,11.8, and 39.4 in.) from the product. and in the beam.

Should there be a device containing a number ofisotopes and designed with a range of dimensions, a distributor may commit to ensuring that the radiation levels do not exceed a specified level. If this is the situation, the certificate needs to include the maximum allowable radiation level and include limitations conceming the installation of the device.

12.9 Quality Assurance and Control This section includes a summary of the GC procedures that will be followed to ensure the product meets all applienble specifications. If the GC procedures meet a national or industry standard or regulation, it is specified in this section, in lieu of submitting GC procedures, an applicant may commit to following a GA program. Again,if:Se GA program meets a national or industry standard or regulation, it is specified in this section. If the applicant commits to following a complete GCor GA program, a short summary of the program may be included and this section should reference that details of the complete program are on file with tne NRC. The

~

section also contains s statement reflecting that the GC or G.4 program has been assessed and deemed acceptable by the NRC.

12,10 Limitations and Other Considerations of Use This section establishes the limiting con itions imposed on the sealed source or device. These include leak testing, handling, storage, use, transfer, disposal, environmental conditions, labeling, special handling procedures and tools, and specific licensing conditions that should be addressed by the license reviewer. This section needs to clearly indicate the services that may be performed by general-licensed users of the products, state that sources or devices should not be subjected to environments that exceed their ANSI or ISO classifications, and state that if subjected to such envirnnments, the licensee must discontinue use of the source or device until a demonstration that no afTect to the source or device integrity has occurred as a result of operation outside the specified range it also includes a limitation that states that the registration certificate and the information contained within the references shall not be changed without the written authorintion of the NRC.

12 3 NUREG-1556, Vol. 3 (draft)

Limitations on scaled sources and devices can be divided into two categories, the first being limitations placed on the manufacturer or distributor of the scaled source or device and the second being limitations placuj on the user of the scaled source or device. Limitations of the first category are derived from regulations. In addition to regulations, the second category of limitations is also derived from conditions imposed by the manufaciurer, by particular conditions of use that would reduce the radiation safety of the device, and by circumstances unique to the scaled source or device, which require that the scaled sowce or device receive a special limitation.

In addition, this section of the certificate may contain reviewer notes. The purpose of such notes is to identify to license reviewers areas of use of the product that cannot be controlled as part of the registration. This alerts the license reviewer to verify that the licensee implements certain administrative procedures before initial use, as part of routine use, or as part of an emergency response to an incident. For example, indicating in a reviewer note that a vendor.io longer ofTers sersiring for the product alerts the license reviewer to obtain more than a statement that services will be provided by the vendor.

12.11 Safety Analysis Summary This section summarizes the conclusion of the evaluation performed by the reviewer and states that the product is acceptable for certs i' censing conditions. Also, typically listed in this section are any additional features that e.e device, surroundings, environment, or accessories may contribute to the integrity or safety of the product. These may include physical constraints such as barriers, fences, or guards and actual use time in terms of radiation exposme resulting from working around the product.

12.12 References This section incorporates by refunce the documents that were submitted in suppon of the application. These references include applications, letters, faxes, electronic nail messages, and enclosures to such documents. The applicant is required to adhere to the information and commitments included in these references.

12.13 issuing Agency This section identifies the NRC as the regulatory agency that issued the certificate and includes the date issued and the typed names and signatures of the two persons who reviewed the certificate and all applicable documentation. All certificates include two signatures as part of the quality control measures.

NUREG-1556, Vol. 3 (draft) 12-4 1

12.14 dttachments -

This section typically contains diagrams, drawings, sketches, or pictures of the product, as discussed previously in Section 12.5. These provide inspectors a tool by which they can easily identify the devices in the field. The cttachments also may contain designations of specific models and their characteristics, such as dimensions and sealed source activities, if a series of devices are registered.

The header for the attachments is.timilar to that for the main body of the registration certificate. The header contains the title of the document, registration number, date of issuance, and attachment numbering. The header does not contain the sealed source or device type. -

12.15 Dimensions and Use of Dual Units The NRC's Metrication Policy (57 FR 46202) requires that documents specific to a registration certificate holder, such as the registration certificate, include dimensions in the units employed by the registration certificate holder. In addition to including the units employed by the registration certificate holder, it is recommended that registratio-rtificates include dual-units as specified below:

All measurements should be stated in the units employed by the registration certificate holder, followed by the appropriate English or Intemational System of Units conversion in parentheses.

All measuiements not provided by the applicant should be specified in English units, followed by the converted Intematiomd System of Units value, The method of stating measurements for a specified property should be consistent a

throughout the document. If the measurement of the property is first stated in Intemational System of Units, with the English conversion in parentheses, then all other measurements should be stated in Intemational System of Units, with the English conversion in parentheses.

If a value is being restated (i.e., the measurement is included in a table, was already stated in the same section of the document, or was included on the first page of the document (such as the maximum activity)), the restated measurement need not have the conversion following it since the conversion has already been included in the document.

/

12-5 NUREG-1536, Vol. 3 (draft) l l

.13 MODIFICATIONS TO EXISTING REGISTRATION CERTIFICATES It is the obligation of the registration certificate holder to keep the registration certificate current.

If a registration certificate holder plans to make a change to the registered product that affects the commitments made in the information provided in support of the application or the conditions included in the registration certificate, the registration certificate holder must file for an amendment or correction to the registration certificate. Until the amendment request is approved and the amended certificate is issued, the registration certificate holder is obliged to comply with -

the information in the certificate. Registration certificate holders are encouraged to anticipate the need for certificate amendments as far in advance as possible.

An application to amend a certificate should be prepared in triplicate. The registration certificate holder should retain one copy for their records and submit the original and one additional copy to the address specified in Section 7. The application should identify the registration certificate by number and should clearly describe the changes and the efTects of the changes on the safety properties of the product. References to previously submitted information should be clear and specific and should identify that information by date, document title, and page number.

An application to amend r. certificate should be accompanied by the appropriate fee (Section 8) and, for medical products, the registration certificate holder needs to notify FDA about the proposed changes to the product.

The request for an amendment or correction needs to address the changes to the product and how the changes afTect the original safety evaluation of the product. The reviewer needs to evaluate the changes to determine if they have any adverse efTects on the safety of the product and whether the initial evaluation and the determination of adequacy are still valid. The reviewer needs to look at all aspects of the initial evaluation to determine if the change would have an effect on another aspect of the evaluation that may not be readily evident. For example, changing a part of the source holder from stainless steel to lead may improve the shielding efliciency, but may have detrimental effects on how the device will react to accident conditions.

This type of detrimental efTect may have been overlooked by the manufacturer.

13.1 Amendments lf the registration certificate holder requests an amendment to the certificate ( i.e., it requires a safety evaluation to be performed), the certificate should be amended in its entirety. The certificate header should include, under the title, the following:

(AMENDED IN ITS ENTIRETY)

The certificate should be assigned a new issue date and the certificate should be re-issued in its entirety. When possible, the reviewer should use bold type face to highlight the changes that have been made to the certificate.

13-1 NUREG-1556, Vol. 3 (draft)

13,2 Corrections If the change only involves corrections to the cenificate (i.e, does not require a safety evaluation to be performed such as change in address or error identified in the cenificate), then only the affected pages of the certificate need to be updated and issued. The reviewer should use bold type face to make the corrections. Each affected page should include,in the header, under the title, the words " CORRECTED PAGES," the number of each oage afTected, and the date of the urrection. An example of this fonnat is shown below:

(CORRECTED PAGES 1,2, & 4 JULY 5,1776)

The issue date of the certificate should remain the same as the last issue date. It is not necessary to include the letter from the registration certificate holder in the reference section of the certificate, if the correction requires a change to the signattire page of the certificate, the certificate should be amended in its entirety. The reviewer may elect to hold off making corrections to the signature page until the registration certificate holder requests an amendment, requiring a safety evaluation, to the certificate.

13,3 Conibining Registration Certificates Registration certificate holders may request that NRC combine two or mwe certificates into a single certificate. Ilowever, it is IMNS policy that only products which are essentially identical in design, ftmetion, construction, and which vary only in a dimensional capacity, in the sources used or in their application, may be grouped together on a single registration certificate.

Combining registration certificates does not require a safety evaluation. Ilowever, the reviewer must detennine whether the request meets IMNS policy and can administratively combine the registration certificates.

13,4 Transfers to inactive Status if a registration certificate holder requests that a registration certificate be transferred to inactive status", the registration certificate holder should provide: (1) the total number of the products sold; the number of products still in use"; (2) the senices (including source replacement and availability) the registration certificate holder will still provide to uscrs of the product or the identification of an entity that will provide services; (3) a commitment that the registration

" NRC also will transfer a registration certincate to inactive status ifit knows the registration certincate hotder is out of business.

" The actual number of products sold and still in use may not be known by the registration certi6cate holder. Ilowever, the registration certincate holder should still provide a best estimate.

NUREG-1556, Vol. 3 (draft) 13-2

l certificate holder will no longer commercially distribute the product; and, (4) verification that no changes were made to the product since its initial registration or last amendment. The reviewer must verify that the above infonnation is included and that the background file for the product evaluation is complete and accurate. Because some registrations were issued many years ago,-

the files may not include all the information that is now required. Therefore, the reviewer should request that the registration certificate holder submit any and all additional information that would be needed to make a determination that the product is acceptable for licensing purposes.

The reviewer needs to write an updated registration certificate, including tl.e new registration number (see Appendix I for issuance ofinactive registration certificate numbers) and updated information. The new certificate will contain a statement that the product will no longer be commercially distributed but may still be approved for licensing purposes. The registration certificate will replace the old registration certificate and will be used as the basis for continued licensing of the product.

13.5 Re-Activating inactive Registration Certificates Vendors may submit requests to re-activate inactive registration certificates. Requests to re-activate inactive registration certificates are handled in one of the two methods:

1.

If the background information on file with she NRC for the inactive registration certificate is complete, up-to-date, and the vendor does not request any changes to the infonnation, the vendor may simply submit a letter to the NRC requesting re-activation of the registration certificate. The letter must include commitmerts that the infonnation on file with the NRC is complete and accurate and that the vendor commits to abide by all infom1ation on file with the NRC. The reviewer must verify the infonnation is complete prior to assigning a new regist ation certificate number and re-issuing the certificate.

2.

If the background information on file with the NRC for the inactive registration certificate is incomplete, not up-to-date, or the vendor requests changes to the infonnation (e.g., changes in the design of the product or manufacturing or distribution procedures), the vendor must submit a complete application for evaluation and registration in accordance with this document. The reviewer must review and evaluate the application in the same manner as a new application.

13-3 NUREG-1556, Vol. 3 (draft)

-14 IDENTIFYING AND REPORTING DEFECTS AND NONCOMPLIANCE AS REQUIRED BY 10 CFR PART 21 Registration certificate holders are required to adopt appropriate procedures to evaluate deviations in product designs or failures to comply with registration requirements to identify defects or failures to comply that are associated with a substantial safety hazard. A substantial safety hazard is defined in Part 21 as a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed, other than for export, pursuant to parts 30,40,50,60,61,70,71, or 72.

However, NRCInformation Mrice 91-39: " Compliance with 10 CFR Part 21, Reporting of Defects and Noncompliance"(available from the NRC upon request) indicates that from a radiological perspective, a substantial radiation safety hazard exists if there is a potential for a moderate exposure to, or release of, licensed material. Further,it provides the following for determining moderate exposure or release oflicensed material:

= Guidelines for detennining moderate exposure:

• Greater thrn 250 mSv (25 rem) exposure (whole body or its equivalent to other body parts) to occupationally exposed workers in a period of a year or less.

• Greater than 5 mSv (0.5 rem) exposure (whold body or its equivalent to other body parts) to an individual in an unrestricted area in a period of a year or less.

• Guidelines for determining potential for release oflicensed material:

• Release of materials in amounts reportable under the pmvisions of 10 CFR 20.2202(b)(2).

All defects or failures to comply that are associated with, or could lead to, a substantial safety hazard must be reported to the NRC pursuant to 10 CFR 21.21. In addition, registration certificate holders are required to meet the posting requirements specified in 10 CFR 21.6.

Applicants are not required to submit copies of the procedures that are necessary to meet the requirements of 10 CFR Part 21. However, applicants need to be aware of the need for such

. procedures and the NRC will evaluate the procedures during inspections.

14-1 NUREG 1556, Vol. 3 (draft)

15 GLOSSARY Active Registration Certryicate means a registration certificate for a sealed source or device that may be authorized for initial distribution. It constitutes part of the basis for the NRC and Agreement States to issue licenses.

Active l'endor means a vendor, listed on a registration certificate, that may be authorized to initially distribute the sealed source or device listed on the registration certificate.

Agreement State means a State that has entered into an agreement with the NRC allowing the State to regulate the use of byproduct material within the State. A complete listing of the cunent Agreement States, including addresses and points of contacts, can be obtained from OSP.

Agreement State Registration Certificate means a registration certificate, issued and maintained by an Agreement State, for a sealed source or device evaluated by the Agreement State.

Applicant means a vendor or custom user of a product that applies for a certificate of registration with the NRC or an Agreement State. The applicant is responsible for ensuring the information provided in the application is complete and accurate.

Associated Eqwipment is equipment that is used in conjunction with a device and directly effects the safe use of the device or ensures the device maintains its integrity (e.g., parts that move a source, cont al the shielding of a source, control the radiation levels around a device, come in contact with the source). Associated equipment supplied by the vendor of the device should be evaluated and registered as part of a device. If the associated equipment is supplied by another vendor, the evaluation and registration should be handled the same as a device evaluation and a separate registration certificate should be issued for the equipment.

Custom User means a licensee that uses a product that is manufactured in accordance with the unique specifications of, and for use by, a single applicant. Typically, no more than two different NRC or Agreement State licensees may be custom users of, and may register, the same product. Ilowever, a custom user may acquire and/or use more than one product.

Inactive Registration Certrylcate means a registration certificate for a sealed source or device that may have been authorized for distribution at one time but no longer may be authorized for initial distribution. Unless otherwise stated in the registration certificate-the sealed source or device included on an inactive registration certificate still may be authorized for use and may continue to be licensed. The vendor listed on the registration certificate may be authorized to provide service and replacement parts for the scaled source or device and may be authorized to receive the sealed source or device from a user for disposal or redistribution to a licensee. However, the design of the scaled source or device cannot be changed.

The NRC and the Agreement States may continue n issue licenses to persons to use sealed sources or devices that are included on an inactive registration certificate. This typically would occur during renewal of a license, llowever, the fact that the registration certificate is inactive 15-1 NUREG-1556, Vol. 3 (draft) i t

I

l serves to alert the license reviewer that the user may not be able to ind a firm to service the device or may not be able to find replacement parts. The license res wer must ensure that emergency procedures, operational support, and services are still applicable.

Inactive Vendor means a vendor who no longer may be authorized to initially distribute the scaled source or device listed on a registration cenificate but may be authorized to provide services for the sealed source or device.

NARM stands for Naturally occurring or Accelerator-produced Radioactive Material. This material is not subject to regulation by the NRC but is regulated by the States. FDA Center for Devices and Radiological Health a..'sts States in their review and regulatory approval for di:;tribution of devices containing NAluf.

Product means any sealed source, device, or associated equipment registered with the NRC or an Agreement State.

Registration Certificate Holder means a vendor or custom user of a product that holds a certificate of registration with the NRCor an Agreement State. The registration certificate holder is responsible for ensuring the information in the registration certificate is current and correct and for ensuring products menufactured or distributed conform with the conditions of the certificate.

Vendor means any person, licensed or unlicensed, who manufactures or distributes products.

Working Life means the time period when the product is expected to maintain its integrity. The working life should is based on the radiotoxicity, total activity, product construction, normal operating environments, likely abnormal conditions, fatigue, and wear.

I NUREG-1556, Vol. 3 (draft) 15-2

APPENDIX A MEMORANDA BETWEEN C. PAPERIELLO AND S. TREBY REGARDING LICENSING OF SEALED SOURCES AND DEVICES EVALUATED AND REGISTERED BY AGREEMENT STATES

l l

Appendix A: Mernoranda between C. P iperiello and S. Treby Regarding Licensing of Sealed Sources and Devices Evaluated and Registered by Agreement States-p "%,,

.N k

UNITED STATES

[$ /j

)

NUCLEAR REGULATORY COMMISSION T#

"'"RVTothT""'

MEMORANDUM FOR:

Stuart A. Treby Assistaut General Counsel for Rulemaking and fuel Cycle Office of the General Counsel FROM:

Carl J. Papo tello, Director Division of Industrial and Medical Nuclear Safety, NMS$

SUBJECT:

LICENSING OF SEALED SOURCES AND DEVICES EVALUATED AND REGISTERED BY AGREEMENT STATES The purpose of this memorandum is to ensure that OGC has no legal objection to the actions we plan to take with respect to registration certificates issued by Agreeme..t States and to request that OGC provide answers to two specific questions concerning Agreement State licensees using sealed sources or devices under reciprocity. We are providing the following background information to assist you in making you? determination and answering the questions.

The Atomic Energy Comission, and now HRC, staff has evaluated sealed source and device designs from a health and safety standpoint since the old Ig50's.

Although the extent of the review was shif ted from a health physics point of

~

s view to an engineering base 1 evaluation, the process has reeatned intact.

Once the product is found to be acceptable for Itcensing purposes, a registration certificate is prepared and issued for the prrJuct. This which practice was conducted under the general prowlstoct of 10 CFR 30.33,f, among states that an application for a specific license w1.: be approved i other things, 'the applicant's proposed equipment and factittles are adequate to protect health and minimize danger to life or property.'

With respect to certain equipment, applicants for specific licenses frequently describe the equipment by referring to data already filed with the NRC by the equipment manufacturer. This practice is administratively convenient to the NRC, Agreement States, manufacturers of aquipment, and applicants for licenses to use the equipment because it eliminates performing redundsnt evaluations and simplifies paperworit. A single submission by a manufacturer is evaluated by the NRC, or an Agreement State, and the results of the evaluation are used in the NRC's or Agreement States' review of multiple applications for specific licenses as the basis for approval. TMs practice is provided for undee the general provisions of 10 CFR 30.3:f a} Atch states, in part, that 'Information contained in previous applicatic'is, statements or reports filed with the Comeission or the Atomic Energy Comissten may be incorporated by reference, provided that the reference is clear and specific."

In 1982 a new management control system for sealed source and device evaluations was implemented. This system estabitshed the current standard format for registration certificates, ustablished the classification of active or inactive for vendors and products, and automated the search and retrieval A-1 NUREG-1556, Vol. 3 (draft)

~ ~. - ~ ~..

- -. ~. _.

3-h

?

^

-3.

1-1

=

=2 Mr.;$tuart A, Treby s

1 i

of certain'information abodt the sealed source and device. At'thatTtime. NRC-- i

._ undertook the task of maintaining a national registry of all egistration 1

certificates for sealed sources'and devices.

- In I N$ the states requested that NRC incorporate the Radioactive Material--

' Reference Manual (RNRN) into the national registry 6,. a service to the States.-

The INIM contains evaluation information on natqrally occurring or accelerator produced radioactive material (NAlWI).. IIRC had no objectt0n to this merger '

. provided that a disclaimer was added to the IWWWI certificates.that clearly denoted that NRC has no authority to' regulate IIARM.: Approximately 500 IWIRM.

l evaluation certificates have been entered into the nattenti-registry.

in IgSf. 10 CfA 30.32(g) and 10 CfR 37.210 were added to codify the existing administrative practice for performing ' pre-marketing' evaluations-and -

,-registrations of radiation safety information on certain sealed sources and devices. '10 CfR 30.32(g) clarifies that an appilcation-for a specific license to use a sealed source or device reference a registration certificate issued by NilC or an Agreement State. 10 CfR 32.210 describes the NRC criteria for approving sealed source and device designs and c16 rifles the regulatory responsibility of manufacturers of products registered with the NRC. These rules provide some assurances that> safety evaluations are performed uniformly.

Although these were not made a matter of compatibility with the States,.the states do recognize the advantages of-participating in performing the b

evaluations and recognizing registrations issued by IIRC or other States.

. n.

(

As part of maintaining the national' registry of registration certificates, the NRC provides the Agreement'5tates copies of the registration certificates they have issued and the State provide copies of the registration cert *ficates.they have issued to the NRC. Thus, when a manufacturer or distributor of products

()

within either an Agreement State's or NRC's regulatory jurisdiction provides detailed information about its sealed source or device to its regulatory agency for registration. -the registration certificate is available to the Agreement' States and NRC for use in granting licensing approval to users of the source or device throughout the United States, its territories and possessions, and in Puerto Rico.

When a registration issued by an Agreement State is forwarded to OSP, OSP is responsible for performing a review of the certificate. In some cases the sealed sources or devices cennot=be licensed by NRC. The same source or

'~

device may be licensed by an Agreement State due to differences between HRC

,e and Agreement State regulations.

y 6;

Based on the above discussion, we plan to do the following:

1.

Continue to incorporate NAllM certificates into the national registry

'af ter the Office of State Programs (05P) has reviewed the certificate 7

c and added the disclaimer that the material covered by the certificate is not regulated by NRC.

a p

NUREG.1556, Vol. 3 (draft)

A-2 i

w'

-. -, - -.A,.

--,s'.-n-n.

s

--=-.m

.+....-,-,--.--r IN <

-,.mm w

a n.n-,ww.4

l Mr. Stuart A. Treby 3

2.

Cantinue to incorporate registration certificates for sources and oevices containing byproduct material for use only within the Agreement State into the national registry after OSP has reviewed the certificate.

An example $f these types of certificates are those which specify the source or device is only approved for use by a custom user.

3.

Incorporate registration certificates for sources or devices which NRC believes may not provide an adequate level of safety or are prohibited for use by certain provisions of NRC regulations into the national registry with a cover letter indicating d y the source or device is not approved for use by NRC licensees. NRC will then address the safety issues with the State which issued the certificate.

We believe this action is necessary to: (1) ensure that NRC license reviewers are aware of NRC concerns with the certificate, if the certificates and cover letters are not included an NRC license reviewer may receive a copy of the certificate directly from the appilcant or Agreement State and assume the registration was accepted by NRC but the registry had not been updated to include the registration; and (2) provide other Agreement States with the informattron necessary to determine whether a license to use the source or device thould be approved.

If OCC has no legal objection to the actions listed above, we request that CCC provide ansmc.s te the following questions:

1.

Can an Agreement State licensee use a sealed source or device under the general license provided in 10 Cid 150.20(a) if the NRC has determined the source or device is not acceptable for licensing purposes for either of the reasons provided in ites 3 sbove? It would appear the use of some sources or devices would be a4thorized as long as the licensee's activities -

,y with the provistans specified in 10 CFR 150.20(b). If x

OGC agree

• J.20(a) could allow Agreement State licensees to perform activities which NRC does not authorize within NRC jurisdiction. An example of this is an Agreement State licensee could perform, in NRC jurisdiction, certain mobile nuclear services which are prohibited under 10 CFR 35.29. This appears to be authorized since 10 CFR Part 35 is not listed in 150.20(b) as a condition of the general license and parts of 10 CFR Part 35 were not a matter of compatibility with the Agreement States.

2.

If OGC determines that an Agreement State licensee can use a sealed source or device under the general license provided in 10 CFR 150.20(a),

what actions can MRC take to prohibit the use of a source or device that NRC has determined is not acceptable for licensing purpests under the general licensef Based on the case involving Wrangler Laboratories, a general licensee, and the case involving the 3M static eliminator probles it is not clear that a general license can be revoLed or suspended to an individual without rulemaking.

1 A-3 NUREG-1556, Vol. 3 (draft)

.m__

. _ _ _ _ _. -.. _ _. _ _ _.. _ _ _ _. _ _.. ~. _ _ _ _ _. -. _,. _.

J

=

1

.i i

l c

4

t-i,

a'

'~

Mr.$tuart'A.Trebyl 4:.

Please' address your responte to this memorandum to Steven Ba99ett of sy staff

=

. at 504 2689, nellsto) OWFN 6H3.

uV 1O CarlJ.dpert o Ofrector

- Division of Industrial and -

Medical Nuclear Safety, ISISS i

t f I NUREG-1556, WL.3 (draft)

A.

l

/** *'%

UNtTED STATES p-NUCLEAR REOULATORY COMMissl0N wasmwatoe e c assspen December 23,1993 MEMORANDUM TOR Carl J. Papariello, Director Division of Industrial and Medical Nuclear Safety DMice of Nuclear Material Safety ar.d liafeguards FROM:

Stuart A. Treby Assistant General Counsel for Rulemaking and Fuel Cycle Office of the General Counsel

SUBJECT:

LICENSING OF SEALED SOURCES AND DEVICES EVALUATED AND REGISTERED BY AGREEMEhi STATES In your memorandum dated September 30, 1993, you requested our views on two specific questions related to the approval and registration of wealed sources or devices by Agreement States, and their subsequent usa-Agreement State licensees under the reciprocity provisie*

'. 0 CFR Ptrt 150.

For the reasons discussed relow, the int State licensee is not authorized to carry out activities 1.,...rAgreement States, if NRC licensees are barred by NRC regulations from conducting such activities.

OuratigILl:

Can an Agreement State licencee une a sealed source or device under the general licenre provided in 10 CFR 150.20(a) if the NRC has determined the source or device is not acceptable for licensing purposes because to) the NRC believes the source er device does not provide an adequate level of safety; or (b) NRC regulations prohibit the use of such source or device?

Reseennes From our reading of the regulations, cources licensed by an Agreement State, and prohibited by NRC regulations, are not authorized for use in a non Agreement State. The example that yo1 cite, certain mobile nuclear services prohibited under 10 CFR 35.29, is invalid.

The provisions of 10 CFR 150.20 are clear, 'Notwithstanding any provision to the contrary in any specific license issued by an Agreement State..., the general licenses provided in this section are subject to the provisions of..

3D.34, 10 CFR 30.34,

' Terms and conditions of licenses,' specifically sets forth in subsection (a) : 'Esch license issued pursuant to the regulations in this part and the regulations in parts 31 through 35 and 39 of thic chapter shall be subject to all the provisions of the Act, now or hereaf ter in ef fect, and to all valid rules, regulations and orders of the Commission.'

This catchall provision has the effect of A-5 NUREG-1556, Vol. 3 (draft)

l 2

capturing the prohibitions of 10 CTR 3 5. 2 9.

The intent of the Commission in promulgating the reciprocity provisions in 1962 was to allow a valid Agreement State licensee the privilege to conduct licensed activities in non Agreement 11tates under a Federal general license, and subject to licensee complianu, with NRC regulations.'

Agreement State licensees are not authorised to conduct

Thus, activities in non Agreement States, unless such activities are also authorized by the NRC.8 ouestion 2:

If 000 determines that an Agreement State licensee can use a sealed source or device under the general license provide in 10 CFR 150.20(a), what actions can NRC take to prohibit the use of a source or device that NRC has determined is not acceptable for licensing purposes under the general license?

Remoonsei Based on our response to question 1.

this situation should not arise. If an NRC licensee is barred from carrying out certain activities, an Agreement State licenser would also be barred from carrying out identical activities under an Agreement State license in the non-Agreement State.

The question remaining involves the activities of Agreement State licensees in Agreement States. If the NRC has reason to believe a safety issue exists with respect to a particular source or device, then the use of the source or device can clearly be banned in non-Agreement States via the reciprocity provisions of Dart 150. With respect to activities in the Agreement States, we would believe that consultation by NRC staff with the Agreement States in question might resolve the issues i.e., the Agreement States would agree to ban the source or device.

It consuXtation with the Agreement States proved insufficient to resolve the issue, the NRC can take steps. pursuant to Section 274j of the Atomic Energy Act of 1954, as amended, to suspend all or part of the Agreement State 1rJ: 27 Eg1 h 1351, Statement of Considerations for 10 CFR Part 150 rulemaking. 'Cxemptions and Continued Regulatory Authority in Agreement States Under Section 274."

8 10 CFR Part 150 does not explicitly set forth every specific URC regulation. However 10 CFR 30.34 has the effect of captunng those requirementa not specifically alluded to in 10 CFR 15 0. 2 0 (b), which should be included as terms and conditions of the specific Agreement State licenses operating in non Agreement It should also be noted that this ' capture" provision does States.

serve to bring in every omitted NRC regulation in Part 150.

not For example,10 CFR 30.33 on ' General Requirements for Issuance of Specific Licenses." would not be relevant.

The corresponding sections of Parts 40 and 70 (Sections 40.41 and 70.32) are also referenced in 10 CFR 150.20 (b? as applicable to Agreement State licensees.

NUREG 1556, Vol. 3 (draft).

A-6

3 program, with or without notice to the State, depending on whether an emergency situation was present.

Finally, we have no legal objection to the actions you are proposing to take with respect to the national registry.

If you require further assistance on these matters, feel free to call navid J. Futoma of my staff at 504-1621.

l Stuart A. *freby Assistant Ge;~ral Counsel for RJ1e'aaking and Fuel Cycle Office of the General Counsel cc: Richard L. Bangart. OSP A-7 NUREG-1556, Vol. 3 (draft)

l' 4

APPENDIX B CHECKLIST FOR REQUESTS TO WITHHOLD INFORMATION FROM PUBLIC DISCLCSURE

Appendix 8: Checklist for Requests to Wthhold Information from Public Disclosure Checklist for Requests to Withhold Information from Public Disclosure in order to request that the NRC withhold information contained in an application from public disclosure, the applic:nt must submit the infennation and application, including an amdavit, in accordance with 10 CFR 2,790.

The applicant should submit all of the following:

A proprietary copy of the information. Drackvts should be placed around the material considered to be proprietary. This copy should be marked as proprietary.

A non-proprietary copy of the information. Applicants should white out or black out the proprietary portions (i.e., those in the brackets), leaving the non proprietary po'tions intact. This copy should NOT be marked as proprietary, An amdavit that:

[

is notarized.

Q.

g#

Clearly identifies (such as by name or title and date) the document to be withheld, i

g'h upper-level management omeial who has been delegated the function of reviewing the information sought Clearly identines the position of the person executing the amdavit. This person must be an omcer or "1

to be withheld and authorized to apply for withholding on behalf of the company, y?

Q States that the company submitting the infomiation is the owner of the information or is required, by

}

agreement with the owner of the information, to treat the infonnation as proprietary.

r;

<, y Provides a rational basis for holding the infonnation in conCdence, j

Fully addresses the following issues:

Is the infonnation submitted to, and received by, the NRC in con 6dence? Provide details.

f To the best of applicant's knowledge, is the information currently available in public sources?

[Y Does the applicant customarily treat this infonnation, or this type of information, as confidential?

9 Explain why, t

Would public disclosure of the information be likely to cause substantial hann to the competitive position of the applicant? If so, explain why in detail. The explanation should include the value of the information to your company, amount of effort or money expended in developing the l

l information, and the case or dimculty of others to acquire the infornution.

Withholding from public inspection shall not affect the right, if any, of persons properly and directly concemed to inspect the documents. If the need arises, the NRC may send copies of this information to NRC consultants working in that area. Tne NRC will ensure that the censultants have signed the appropriate agreements for handling proprietary informatic if the basis for withholding this information fmm public inspection should change in the future such that the information could then be made available for public inspection, the applicant should promptly notify the NRC. The applicant also should understand th:t the NRC may have cause to review this detennination in the future, for example,if the scope of a Freedom cf Information Act request includes the information in question, in all review situations, if the NRC makes a determination adverse to the above, the applicant will be notified in advance of any public disclosure.

B-1 NUREG-1556, Vol. 3 (draft)

I

1 APPENDIX C APPLICATION AND REVIEW CHECKLIST l

l l

l l

i i

l w-ay-,-

w g

e

-wc4 k

rw-g y

3ppendix C:? Applicati:n cnd R; view Checklist i

SUMMARY

DATA N:me and Complete Mailing Address of the Applicaat:

Name, Title, and Telephone Number of the individual to Be -

Contacied if Additionalinformation or Clarification is Needed by the NRC:

g

~f The Applicant is (check one):

If the Applicant is Not the Manufacturer, Provide the Name and Complete Mailing Address of the Manufacturer:

Manufacturer -

0 Distributor -

Manufacturer and Distributor if the Applicant is a Custom User, Provide the Name and Provide the Name, Complete Malling Address, annunction of.

Complete Malling Address of the Distributor:

Other Companies involved:

ModelNumber:

Principal Use Code (see Appendix D):

NIme Used by the Industry to_ identify the Product (e.g.,

For Use by:

R:diography Esposure Device, Teletherapy Source,;

Specific Licensecs Only Celibr: tion Source, etc.):

General Licensees Only Both Specific and General Licensees Persons Exempt from Licensing Leak Test Frequency:

Principal Section of the 10 CFR that Applies to the User (e.g.,

General Licensees under 10 CFR 31.5):

Periodic Leak Testing is Not Required L

6 Months Radionuclidcs and Maximum Activities (including loading Attached is justification for a leak test frequency of greater than 6 months.

CERTIFICATION:

TltE APPLICANT UNDER$TANDS TilAT AllSTATEMENi$ AND REPRESENTATIONS MADE IN Tlus APPLICADON ARE BLA)!NG UPON Tile APPUCANT.

TllE APPLICANT AND ANY Of FlCIAL EXECUTING TIDS CERTtTICA110N ON DElfAlf OF Tile APPLICANT, NAMED IN TTEM 2, CERTIFY TIIAT T105 APPLICATION IS PREPARED IN CONFORMITY %TDI TITLE 10.c0DE OF f EDERAL REGULATIONS, PnRTS 30 AND 32 AND TilAT ALL INFORMATION CONTAINED IIEREIN 15 TRUE AN13 cC'. RECT TO TIIE BEST OF TilEIR KNO%UDGE AND DEL!EF.

l WARNING tt U S C. EECTION B001 ACT OF JUNE 25, lH862 STAT. 749 MAKES fl A CRIMINAL OfTENSE TO MAKE A willfully FALSE STATEMENT OR -

l REPRESENTAT10N TO ANY DEPARTMENT OR AGENCY OF Tit" UNTTED STATES AS TO ANYMATTER %TDIIN TT5 JUR15DtCTION

~l 4

Ccrtifying Officer-Typed Name and Title -

L Signate:

Date:

L 1

C-1

. NUREG-1556, Vol.' 3 (draft).

J m

l I

- Page 1 of'4 CHECKLIST Registration Certificate Holder:

Model:.

DESCRIPTION OK/DEF COMMENTS DESCRIPTION / CONSTRUCTION If registration certificate holder is requesting to register more than one soureddevice on a certincate, are designs similar enough to do so?

Device / source design wi'h complete engineering drawings (dimensions, tolerances, list of materials)

Assembly m(thods (screw, welds, etc.);

(

verify integrity l

Source mounting (slie and integrity) and security is source ANSI classincation sufncient (from ANSI N5421977):

Radiography. Unprotected.....

43515 Radiography. in Devica........

43313 Medical. Radiography.........

. 32312 Medical. y Teletherapy...

.53524 y Gauges. Unprotected...

43333 y Gauges. In Desice..

41'.32 p Gauges,l.ow Energy y Gauges, or X. ray fluorescence 33222 Oil Well 1.ogging...

56522 Portable Moist / Density.

43333 Neutron Applications 43323 y irradiators (11.111. IV)

. 43424

' y ltradiaton (l)..

.43323 S% tic Eliminators...

22222 Smoke Detectors.

.32222

- Dennition of st.atter operation (locked in Off position, not locked in On position). Fail safe, spacing and tolerances On.Off indicators (description, qty., location)

Safety interlocks, guards, etc. to prevent access to beam or high radiation levels Corrosion between unlike materials (e.g., aluminum & steel. depleted uranium &

- steel, etc.)

Shi:Idir.g efficiency and integrity

- For medical devices: Was a $10k provided? (provide written notification to FDA) :

Well logging sources must be nondispersible and nonsoluble. (see Appendix 3 for o list of approved well logging sources as of November 1991)

See

• ANSI and Other Standards

• list for references for particular source / device designs (e.g. radiography, lirachytherapy etc.)

C.3 NUREG-1556, Vol. 3 (draft) d

-i l

J Page 2 of 4

/

,N CliECKLIST Hegistration Certificate lloider:

Model:

DESCRIPTION -

OK/DEF COMMENTS j

l LA13ELING Copy of label Materials, dimensions, colors (note on registration certificate if labeling is exempt from the color requirements of 10 CFR Part 20)

Permanent attachment und location (s) visible to users?

Contents: Modet#, Serial #, Isotope, Actigity, Manufacturer, Date of Assay, Trefoil, 'CAlfilON - RADIOACTIVE MATERIAL" (Depleted Uranium information must be included)

CONDITIONS Ol' USE

_.'hpected working life of the source / device (years, operations)

Actions to be taken when pniduct reaches end of its working life.

Masitnum allowable temperature, vibration, shock, corrosion, etc. (duri:.g use, handling, storage, and transport) liow the device will be used Meets dose limits of Part 32 for distribution general licensees or persons exempt frorn licensing PROTOTYPE TESTING /lilSTORICAL l'SE Tests methods and conditions (for source und device)

Tests results Years of use (incidents, failures, etc.)

Similarities to other sources / devices if they are used as basis.

RADIATION PROFILES Survey instrument used (t> pc. window thickness, sensitivity, etc.)

Conditions: including environments, sctter (product in beam), and use of guards end shicids Distance from source / surface (per ANSI 538-1979)

Shutter Open and CloseSSource Shielded 3

Verify radiation surveys for y radiation meet inv law.

Verify radiation r.urveys for non-y radiation have not been calculated using inv'

- law.

NUREG-1556, Vol 3 (draft) -

C-4

f Page 3 of 4 4

CHECKLIST Registration Certificate lloider:

Model: -

DESCitIPTION OK/DEF COMMENTS QUALITY ASSURANCE M:terials. subassernblies, sertices Assembly methods (screws, welding, etc.)

Dirnensions and tolerances

- Activity, radiation sevels, leak icsts QA Manual and cornparison of manual to Regulatory Guide 6.9 (NSTALLATION Thed, portable, mosable, fixed nistallation but portable source housing Inherent shiciding, inaccessibility Ucem access: stic of air gap / opening to beam and use of interlocks, lock,,

additional shieldmg ut barriers Mounting integrity SAI'I:TY INSTRUCTIONS Operttion, maintenance, cutibration, damage! failure, specific warnings, leak test, cnd rediation surveys ACCOMPANYING DOCUMENTATION 1.cak tests results and radiation surveys Tr nsportation documents

. Oper: tion, maintenance, talibration, damage / failure, specific warnings, leak test, and radiation survey instructiorniif applicable for Distribution to General Licensees:

Verify NRC Regions and Agreemec State listing is up to-date and copics of all pertinent regulations C-5 NUREG-1556, Vol. 3 (draf0

o 4.

Page'4 of 4 CHECKLIST Registration Certif:cate Holder:

Model:

DESCRIPTION OK/DEF COMMENTS SERVICING The'following activities may be performed by the persons indicated:

Actitivity by a General Only by a Will be Offered Licensee Specific Licensee by the Applicant Installation Relocation Maisitenance Repair Soune I:xchange Calibration 1.cak Testing Radiation Suncy Training FOREIGN VENDORS Drop ship Who and where is source installed I.cak test and radiation surveys QA in the U.S.

NUREG-1556, Vol. 3 (draft)

C-6

APPENDIX D MEMORANDUM FROM R. SCROGGINS REGARDING WORKING ON APPLICATIONS PRIOR TO RECEIPT OF FEES 1

I I

b I Appendix Di (Memorandum from R. Scroggins Regarding Working on Applications Prior to Receipt of Fees gg i i @

MEMORANDUM FOR:

Thomas T. Martin, Administrator, Ra Stewart D Ebneter, Administrator, Ril

'/..

'Jotus B. Martin, Administrator,-Rill James L, Mllboan, Administrator, RIV Kenneth E. Perkins, Jr., Administrator, RV IROM:

Ronald M..$cr69 gins Deputy Chief Financial Officer / Controller PROCEOURES FOR PROCE$$ LNG MATERIALS LICENSE

. 5USJECT:

APPLICATIONS PRIOR 10 IEE VERIFICATION In the November 1, 1993, Report of Headquarters Organizational Review, the Review Team recommended that the maiertals license review process should not be de).yed to obtain OC fee concurrence. The ED0's January 10, 1994, memorandum to me regarding the Report (copies to office Directors and Regional Administrators) stated: 'The C00 agrees that the vertftcation of fees should not delay the Itcense review process. OC is to work with the

- regions to estabitsh a mutually acceptable mechanism to accomplish the regions accurate identsfication of license fees.* As stated in my January 6, 1994, memorandum to Thomas T. Martin, Region I, copy enclosed.. It is current agency polley not to delay the processing of an appitcation pending the receipt of a Accordingly, applications can be processed up to the peint of issuance fee.

pending notification that the (ee is paid.

If you or any member of your staff have questions regarding this policy or the procedures, or have suggestions for improving the current procedures, please contact Glenda Jackson of my staff at (301) 492 8740, Ctg..

.9 R3M ti..:.aQy Ronald M. Scroggins Deputy Chief Financial Officer / Controller i

l i

D-1 NUREG-1556, Vol. 3 (draft)

?

APPENDIX E PRINCIPAL USE CODES AND DEFINITIONS 1

l 1

,,.-...___m,.,

Appendix E: Principal Use Codes and Definitions CODli A

Industrial Radionanny - The examination of the structure of materials by aondestructive methods that use secled sources of radioactive material.

11 hiedical Radiocrmhy - 1hc r,rocess of prmlucing x ray or gamma ray images to assist in medical diagnoses.

C hiriljallslrlhnny - 1hc treatment of disease whh gamma radiation from a controlled source of radiation located at a distance from the patient.

D Qamma Gauces - 1hc use of gamma radiation to measure or control thickness, density, levels, interface location, radiation leakage, or chemical composition.

E Hr1LQuxo - 1he use of beta radiation to measure or control thickness, density, levels, interface location, radiation leakage, or chemical composition.

F Well leccing - 1hc lowering and raising of measuring devices or tools that may contain radioactive sources into well bases or cavities for the purpose of obtv. ng informat!on about the well or adjacent formation.

O h!rtable M4ture Densitv Gaucu - portable gauges that use a radioactive sealed source 'o determine or measure the content or density of material. Includes hand held and dolly transponed devices with sources.

11 Grneral Neutron Source Anotications - All applications, except reactor startup and well logging, that use a neutron source.

Calibration Soutgn (Activity greater than 30 mCl)- Sources of a known purity and activity that are used to determine the variation in accuracy of a measuring instrument and to ascenain necessary correction factors.

J Da;nma irrndiator. Catecorv i - An irradiator in whic : the sealed source is completely contained in a dry container constructed of solid materials, the scaled source is shielded at all times, and human access to the scaled source and the volumes undergoing irradiation is not ptysically possible because of the design of the irradiator.

K Gamma irradiator. Catecorv 11 - A controlled human access irradiator in which the scaled source is contained in a dry container constructed of solid materials, is fully shielded whcc not in use, and is exposed within a radiation volume thr.t is maintained inaccessible during use by an entry control system.

L Qamma Irradiator. Category til - An irradiator in which the scaled source is contained in a storage pool (usually containing water), the sealed souice is shielded at all times, and human necess to the scaled source and the vo!ume undergoing irradiation is physically restricted in its designed configuration and proper mode of use.

El NUREG t556, Vol. 3 (draft)

.\\

l

CODE M

, Gamma Irradiator. Catecory_lX - A controlled human access irradiator in which the sealed source is contained in a stmage pool (usually containing water), is fully sidelded when not in use, and is exposed within a radiation volume that is maintained inaccessible during ut.e by an entry control system.

N lon Generators. Chromatocraohv - The use of an ion generating source and a device to determine the chemical composition of material.

O lon Generators. Static Eliminators - The use of an lon genciating source and a device to eliminate static electricity on a surface or a surrounding area.

P lon Generators. Smoke Detectors - The use of an ion generating source and a device to detect gases and particles created by combustion.

Q Thermal Generato.t - the use of a radionuclide and a device to produce heat to produce energy.

R Gas Sources - Scaled sources containing radioactive gas such as krypton 85 or hydrogen 3.

S Foil Sources - Sources that are constructed using thin met

' The radioactive material may be secured to the foil in a number of ways, for examp'.

..ig, laminating, or cold welding.

T f.!!htt - All uses not covered in other categories.

U X Ray Fluorescence - Sources and devices that use radioactive material to excite the atoms of samples that in turn emit characteristic x-rays and thereby provide a means for sample analysis.

V General Medical Usg - Includes diagnostic sources and devices such as bone mineral analyrers and therapeutic sources and devices such as interstitial needles, therapeutic seeds, and ophthalmic a[ plicators.

W Selfl.ummons 1.icht Souret - A source consisting of a radioactive nuclide or nuclides incorporated in solid inactive materials or scaled in a protective envelope and incorporating a phosphor to emit light.

X Medical Reference Soure.eji-includes flood sources, instrument check sourtes, spot markers, Y

Calibraton - Devices containing calibration sources that are used to determine the variation in accuracy of a measurirg instrument and to determine necessary correction factors.

NUREG ISS6, Vol 3 (draf1)

E-2

i I

APPENDIX F STANDARD REFERENCE MATERIALS i

i l

)

Appendix F: Standard Reference Materials Avallone, E. A., and llaumeister, T., " Marks' StanJard llandbook for Mechanical

'y Engineering, Ninth Edition," 1987 llelanger, R., iluckley, D. W., and Swenson, J. B., NUREO/CR-ll56 " Environmental Assessment oflonization Chamber Smoke Detectors Containing Am 241," November 1979 Iluckley, D. W., llelanger, R., Martin, P. E., Nicholaw, K. M., and Swenson, J. B.,

NUREG/CR 1775 " Environmental Assessment of Consumer Products Containing Radioactive Material," October 1980 1.inauskas, S.11.," Doses from Portable Gauges,"(Research Report), August 1988 Schweitzer, P. A., "llandboek of Corrosion Resistant Piping," 1969 Shigley, J. E., and Mitchell, L. D., " Mechanical Engineering Design Fourth Edition," 1983 Sbreir, l.1,.. " Corrosion, Volume 1, Metal / Environment Reactions," 1976 Willems, N., Easley, J. T., and Rolfe, S. T., " Strength of Materials," 1981 F-1 NUREG 1556, Vol. 3 (drafi) l_

l

i APPENDIX G INDUSTRY AND CONCENSU3 STANDARDS

]

i i

i 1

l-i l

l m---.

s w-m a

m-e w

.-y..y,-

y--

--.,,,._,g.

p y

p y.

y 3

p.,y w

Appendix G: Industig and Concensus Standards Brachytherapy:

ANSI N44.21973 "For Leak Testing Radioactive Brachytherapy Sources" ANSI N44.1 1973

" Integrity and Test Specifications for selected Brachytherapy Sources" Gauges:

ISO 72051986(E)

"Radionuclide gauges - Gauges designed for permanent installation" ANSI N5381979

" Classification of Industrial lonizing Radiation Gauging Devices" Irradiators:

ANSI N433.1-1977 " Safe Design and Use of Self Contained Dry Source Storage Gamma irradiators (Category I)"

ANSI N43.10-1984 " Safe Design and Use of Panoramic, Wet Source Storage Gamma irradiators (Category IV)"

Light Sources:

ANSI N43.41975

" Classification of Radioactive Self-Luminoas Light Sources" Power Generators:

lAEA No. 33

" Guide to the Safe Design, Construction, and Use of Radioisotopic Power Generators for certain Land And Sea Applications" Radiography:

ANSI N43.91991 "For Gamma Radiography - Specifications for Design and Testing of Apparatus" ANSI N4321980 Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography" ISO 39991977(E)

" Apparatus for Gamma Radiography - Specification" G-1 NUREG 1556, Vol. 3 (draf1)

Smoke Detectors:

Nuclear Energy Agency - 1977

" Recommendation for lonization Chamber Smoke Detectors in implementations of Radiation Protection Standardi' Sources (General):

ISO 29191980(E)

" Sealed Radiation Sources, Classification" ANSI N542-1977

" Sealed Radiation Sources, Classification"

-(Revision of ANSI N5.101968)

ANSI N5.101968

" Sealed Radiation Sources, Classification" Teletherapy:

ANSI N449.1-1978 " Procedures for Periodic inspection of Cobalt 60 and Cesium-137 Teletherapy Equipment" X Ray Fluorescence:

ANSI N43.21977 "Rediation Safety for X Ray Diffraction and Fluorescence Analysis Equipment" ANSI N537-1976

" Radiological Safety Standard for the Design of Radiographic and Fluoroscopic Industrial X Ray Equipment" Miscellaneous:

ANSI N4331993

" Installations Using Non Medical X Ray and Scaled Gamma Ray Sources, Energies Up to 10 MeV" NCRP Report No.49 " Structural Shielding Design and evaluation for Medical use of X Rays and Gamma Rays of Energies up to 10 MeV" NUREG 1556, Vol. 3 (drall)

G2

APPENDIX H STANDARD REGISTRATION CERTIFICATE FORMATS

...m

.=d.mm.

h.

~

Appendix H: Standard Registration Certificate Formats REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO.: NR ***-S

• • • -S DATE:

PAGE 1 OP 5 4

SOURCE TYPE:

Short description of the source type i

MODEL!' ABC f

~

f MANUFACTURER / DISTRIBUTOR Name I

Street-Ci ty, Sta te Zip i

(if manufacturer and distributor i

are the same, keep subheading as shown.

If diffevent, delete the

. word manufacturer from the subheading)

MANUFACTURERt Name Street i'

Ci ty, Sta te Zip (this subheading and information is not necessary if manufacturer and distributor are the same.)

l 1

ISOTOPE 1 MAXIMUM ACTIVITY:

l

'Ioist Isotopes xx millicuries (xx GBq) i units should be such that the i

amount is in the 1 to 999 range j

LEAK TEST FREOUENCY:

Not Required 6 Months

.PRINCIPA5'USE1

^(A) Indus trial - Radiography

{

from lioting in Regulatory Guide 10.11 i

. CUSTOM SOURCE -

YES X

NO

+

CUSTOM USER:

Nhme Street t

Cityr State Zip (delete entire ' subsection if not applicable) ij

H 1-

.NUREG 1556, Vol. 3 (drafi) f k__

i

. a..

u.,

...w

-, _.. ~ _.. _ _... _ -, _.. _ _ _ _ _.. _ _. _.. -.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO.: NR

• • • -S

• • • -S DATE:

PAGE 2 OF 5 SQURCE TYPE:

Short description of the source type DESCRIPTION:

j i

Provide the complete description of the source.

LABELING:

The source is engraved with the radiation symbol, isotope, activity, model number, serial number, date of assay, name of the distributor, and the words " CAUTION-RADIOACTIVE MATERIAL".

The text is X" (X mm) high and is on the end/ side of the source capsule.

DIAGRAM:

Reference all attachments to the document including the total number of attachments.

CONDITIONS OF NORMAL USE:

The sourue is designed and manufactured for use in measuring....

The source may be used in harsh enviroments but shall not be Pubjected to environments that exceed its ANSI NS42-1977 classifica tion, 77COOOOO.

PROTOTYPE TESTING:

A prototype of the Model ABC source was constructed and subjected to the tests provided in ANSI N542-1977/ ISO 2919 and achieved a classifica tion of 77C00000.

NUREG 1556, Vol. 3 (draft)

-112 e

et w-m.N-.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

NO.: NR

• • • -S

• • • -S DATE:

PAGE 3 OF 5 SOURCB TYPCt Short description of the source tri)e EXTERNAL RADIATION LEVELS:

The fallowlng dose tates were reported by the manufacturer for the Model'ABC source containing 1.0 curie (37 GBq) of Am-241:

Table 1 Max 4=nna Radiation Level Distance Trom Window.

From Sidewall /Back (inches)

(cm)

(mR/ht)

(pSv/hr)

(mR/hr)

(pSv/hr) 1.97 5

11.81 30 39.37 100 OUALITY ASSURANCE AND CONTROLL XXXXXX maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NBC.

A copy of the orogram is on file with NRC.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

• The source shall be distributed to persons specifically licensed by the NRC or an Agreement State.

• The device shall only be used by the custom user listed in this certifica te, XXXXX.

• Handlir3, storage, use, transfer, and disposal:

To be determined by the licensing authority.

11-3 NUREG 1556, Vol. 3 (draft)

=.

=--

-w y

.y.

--y y

i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICE 3 SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) l PAGE 4 OF 5 NO.t NR

• • • -S

• • • -S DATEL foURCE TYPE:_

Short description of the source type LIMITATIONS AND/OR OTHER CONSIDERATIONS _OF USE (Cont.):

transfers and disposal:

To be Handling, storage user r

determined by the licensing authority.

In view that these sources exhibit high dose rates, the sources should be handled by experienced licensed personnel using adequate handling equipment and procedures.

The source shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.

The source shall not be subjected to conditions that exceed its ANSI N542-1977 classification, 77C00000.

T'.is registration sheet and the information contained within

• the references shall not be changed without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

Based on review of the Nodel ABC sealed source its ANSI r

classifica tion and the information and test data cited below, we s

(continue to) conclude that the source is acceptable for licensing purposes.

Fur thermore, we (continue to) conclude that the source mould be expected to maintain it's containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.

NUREG 1556, Vol. 3 (draft) 114 w

--,y a

l

/

REGISTRY OF RADIOACTIVE SEALED SOURCES A!1D DEVICES SAFETY EVALUATIO11 OF SEALED SOURCE

-(/,ME!4DED I!1 ITS Et4TIRETY) 14 0. : tJR

• • • -S

• • • -S

,DATE:

PAGE 5 OF 5 SOURCE TYPE:

Short description of the source type

/'

hEFERE11CES :

The followlng supporting documents for the Model ABC sealed source are hereby incorporated by reference and are made a part of this registry documnnt.

• s applica tion da ted December 25, 0000, with enclosures thereta.

• e letters dated July 4, 1776, and December 25, 0000, with enclosures thereto.

• s facsimiles dated July 4, 1776, and December 25, 0000.

I S S U lt1 G A G Ell C Y :

U.S.

11uclear Regulatory Commission Date:

Reviewer:

Name of 1st reviewer Date:

Concurrence:

Name of 2nd reviewer t

11 5 NUREG-1556. Vol. 3 (drall)

REGISTRY OF RADIOACTIVE SEALED SOURCES At4D DEVICES SAFETY EVALUATIO!J OF SEALED SOURCE (A!4EtJDED 114 ITS Et4TIRETY) 1[L.1,14R ***-S

• • • -S DATE:

hI,TICliEli.T_1 KUREG 1556, Vol. 3 (drafl) 1-1-6

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NO.: ilR

• • • -D

• • • -X DATE:

PAGE 1 OF 8 DEVICC TYPE:

Short description of the device type MODELL ABC MANUPACTUPER/ DISTRIBUTOR:,

Name Street City, State Zip (i[ manufacturer and distributor are the same, keep subheading as shown.

If differento delete the word manufacturer from the subheading)

MA11UFACTURER:

Name Street City, Statt Zip (this subheading and information is not necessary i[ manufacturer and distributor are the same.)

SEALED SOURCE MODEL DESIGNATION:

ACME Model 123 ISOTOPFa MAXIMUM ACTIVITY:

List Isotopes xx millicuries (xx GBq) units should be such that the amount is in the 1 to 999 range LEAM TEST FREOUENCY:

Not Required 6 Months PRINCIPAL USE:

(A) Industrial Radiography from listing in Regulatory Guide 10.10 CUSTOM DEVICE:

YES X

NO CUSTOM USEh.

Name Street Ci ty, Sta te Zip (delete ontire subsection if not applicable) 117 NUREG-1556, Vol. 3 (drafi)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

H221 NR

• • • -D

• • • -X DATE:

PAGE 2 OP 8 DEVICE TYPE:

Short description of the device type DESCRI PTIQ1{1 Provide the complete description of the device and, if necessary, the source (s) used in the device.

LABELINGi The device is labeled in accordance wi th 10 CFR 20.1901.

The labels contain the radiation syvbol, isotope, activity, model number, serial number, name of the distributor, and the words

" CAUTION-RADIOACTIVE MATERIAL".

When distributed to persons generally licensed, the device is additionally labeled in accordance with 10 CFR 32.51.

The labels are made of stainless steel or aluminum, rectangular in shape X" x X" (X cu x X cm), and are permanently attached by r

rivets or screws to the device.

A copy of the label is shown in attachment X.

DJ AGRAM:

Reference all attachments to the document including the total number af attachments.

CONDITIONS OF NORMAL USE:

The source is designed and manufactured for measuring....

The dsvices are expected to be subjected to environments typically found in laboratories occupied by humans.

Since the device is portable, it may experience vibration and shock typical during normal transportation.

The device will only be used by XXXV at their XXXXX CITY, ST fa cil i t y.

NUREG-1556, Vol. 3 (draf1) 11-8

REGISTRY OF RADIOACTIVE SEALED SOURCES A11D DEVICES SAFETY EVALUATIO!1 OF DEVICE (AME!1DED I!1 ITS E!4TIRETY) 110.: 11R ***-D ***-X DATE:

PAGE 3 OF 8 DEVICE TYPE:

Short description of the device type CONDITIOf1S OF 140RMAL USE (Cont.):

The devices are intended for use in industrial gauging applications.

The devices are typically used in industrial procesa control envitonmenta for Lhe acasurement o[ properties of materials in a tank or vessel.

The devices are designed for the f0110 wing environments:

Tempe ra t u re................ - 4 C "C t o 6 0 'C (-4 0 *F to 14 0 *F)

Pros a u re................... A tm osph e ri c Vibra tion.................. Ranges from zero to mild corrosion..................Bange.

from zero to highly cc.:osive vapors Fi re....................... NEC Di vi si on. 2 ha za rdous area possible Expl osi on................. NEC Di vi si on 2 ha za rdous area possible PROTOTYPE TESTING:

A prototype of the Model XXXX was constructed and subjected to the tests listed below.

No malfunction occurred not was there any loss of shielding or containment integrity.

• Ten.pe ra t u re................... 1 10 'C (230 'F) for a period of seven hours.

Vi b ra t i o n...................... App rox i m a t el y 3 0 cps a t a n amplitude of 0.03" (0.76 mm) for 90 minutes.

OFF/ON Mechanism............... Opera ted by a pneuma tic cylinder for a total of 9320 OFF/ON cycles.

Impact......................... Dropped three times from a height of 4 feet.

Pen e t ra t i on.................... Dropped a 13 pound (5. 9 Vg),

1-1/4" (3.2 cm) diameter steel rod from a height af 40" (102 cm).

11-9 NUREG 1556, Vol. 3 (draft)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NO.:. NR ***-D ***-X DATE:

PAGE 4 OF 8 DEVICE TYPE:

Short description of the device type PROTOTYPE TESTING (Cont.):

A prototype of the device has been tested in accordance with ANSI / ISO standard.... and has achieved a classi[ica tion of....

The device passed the tests in accordance with the acceptance criteria included in the standard.

The scaled sources used in the device have been tested by their manufacturers and have achieved the following ANSI (N542-1977 or ANSI NS.10-1968) classifications:

Manufacturer Model ANSI Classification Amersham Corporation AMCL 77C64344 Du Pont Merck NER-465 C33232 Isotope Products Laboratories PH-55 C33232 The sealed source contained in the device has achieved an ANSI Nb42-1977 classifica tion of 77C00000.

The scaled source contained in the device has achieved an ANSI N5.10-1968 classifica tion of C00000.

EXTERNAL RADIATION LEVELS:

XXXXXXXXX reports that the radiation levels from the device are not discernable from background.

XXXXXXXXX reports that the radiation levels from the device do not exceed 5 mR/hr (50 pSv/hr) at 12" (30. 5 cm) from the surface of the device.

The following dose rates were reported by the manufacturer for the Model ABC transmission gauge containing a 1. 0 curie (37 GBq)

'of Am-241 sealed source:

NUREG-1556. Vol. 3 (draf1) 11-1 0

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEV'CES SAFETY EVALUATIO!1 OF DEVICE (AMENDED IN ITS ENTIRETY) liq &L NR

• • • -D ***-X DATE:

PAGE 5 OF 8 DEVICE TYPE:

Short description of the device type EXTERNAL RADIATION LEVELS (Cont.):

Table 1 Nkximum Radiation Level Distance Etom Window Trom Sidewall /Back (inches)

(cm)

(mR/hr)

(uSv/hr)

(mR/hr)

(ySv/hr) 1.97

'S 11.81 30 39.37 100 The dose rates were taken with no waterial present in the measuring area.

XXXXXXX indicates this represents the highest radiation levels of any possible configuration.

OUALITY ASSURANCE AND CONTROL; XXXYXX maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC.

A copy of the program is on file with NRC.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

The device shall be distributed to persons specifically licensed by the NRC or an Agreement State.

• The device may be distributed to specific or general licensees of NRC or an Agreement State.

• The device shall be distributed to persons generally licensed by the NRC or an Agreement State.

• The device shall only be distributed to the custom user, XXXXX.

11-11 NUREG-1556, Vol. 3 (draft)

1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF f)EVICE (AMEt1DED Ill ITS ENTIRETY)

NO.: NR ***-D ***-X DATE:

PAGE 6 OF 8 DTSLCE TYPEL Short descript-on of the dovice type LIMITATIONS AND/OR OTHEF

'isIDERATIONS OF USE (ContJ :

transfer, and disposal:

To be

• Handling, storaga, ser determined by the 1. ensing authority.

• Handling, storage, use, transfer, anC disposal:

To be determined by the licensing aut.hority or as required by 10 CFR 31.5 or Agreement State equivalent.

The device shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.

The Model XXXXXX sealed source is approved by NRC for use in the Model ABC.

The source is not regist.eted on a separate certi fi ca t e.

The generally licensed user is authori:cd to perform certain maintenance on the device (see the device opera tion manual).

These services include...

REVIEWER NOTE: Neither the distributor not manufacturer of the device will provide servicing for the device.

This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

The distvibutor has submitted sufficient in[ormation ta provide reasonable assurance that:

The device can be safely operated by persons not having training in radiological protection.

I NURl!G-1556, Vol. 3 (draft) 11-1 2

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NO.: NR ***-D

'**-X DATE:

PAGE 7 OF 8 DEVICE TYPE:

Short description of the device type SAFETY ANALYSIS

SUMMARY

(Cont.):

• Under ordinary conditions of handling, storage, and use of the device, thJ byproduct material Contained in the device will not be selsesed or inadvertently removed from the source hou ing, and it is unlikely that any person will percent of,'ny p triod of one year a dose in excess of 10 receive in. he 'imits specified in Section 20.1201 (a),

10 CFR Part 20.

Under accident conditions associated with handling, storage,

• and use of the source housing, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the following chart:

PART OF PODY DQEE Whole body; head and trunk; active blood-forming organs; gonads; or lens of eyo 15 rem (0.15 Sv)

Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 cm; (0.15 in')

200 rem (2. 0 Sv) 50 rem (0.50 SV)

Other organs Based on review of the Model ABC, and the information and test data cited below, we (continue to) conclude that the device is acceptable for licensing purposes.

Furthermore, we { continue to} conclude that the device would be expected to maintain it's containment integrity for normal conditions of use and-accidental conditions which might occur during uses specified in this certificate.

11-1 3 NUREG 1556. Vol. 3 (draft)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) h NR

• • • -D ***-X DATE:

PAGE 8 OF Q DEV.LCE TYPE:

Short description of the device type

REFERENCES:

The following supporting documents for the Model ABC are hereby incorporated by reference and are made a part of this registry document.

's application dated December 25, 0000, wi th enclosures thereto.

• s letters dated July 4, 1776, and December 25, 0000, with enclosures thereto.

's facsimiles dated July 4, 1776, and December 25, 0000.

ISSUING AGEL{.Cli U.S.

Nuclear Regulatory Commission Date:

Reviewer:

Name oE 1st reniewer Date:

Concurrence:

Name of 2nd reviewer NUREG l$$6, Vol. 3 (dran) 11 14

REGISTRY OF RADIOACTIVE SEALED SOURCES AllD DEVICES SAFETY EVALUATIOli OF DEVICE (A!4Et1DED Ill ITS E!1TIRETY) 14 0. : tJR ***-D ***-X DATE:

ATTACHMEt1T 1 11-1 5 NUREG-1556, Vol. 3 (draft)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATIO!1 OF DEVICE (AMENDED IN ITS ENTIRETY)

((L.i N R * * * - D * * * -X DATE-ATTACHMENT 2 NUREG-1556, Vol. 3 (draft)

H-16 i

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) lili,_1. NR ***-D

• • • -E DATE:

PAGE 1 OF 2 DEVICE TYPE:

Smoke Detector / Gun Sight MODEL:

ABC MANUFACTURER / DISTRIBUTOR:

Name Street Ci ty, State Zip (if manufacturer and distributor are the same, keep subheading as shown.

If different, delete the word manufacturer from the subheading)

[BljUFACTURER:

Name Street City, State Zip (this oubheading a nd information la not necessary if..,anufacturer and distributor are the same.)

4 SEALED SOURCE MODEL DESIGNATION:

ACME Model 123 ISOTOPE:

MAXIMUM ACTIVITY:

Ameri cium-241

1. 0 microcurie (37 kBq)

Hydrogen-3 60 millicurice (2. 2 GBq)

LEAK TEST FREOUENCY:

Not Required PRINCIPAL USE:

(P) Ion Generator, Smoke Detectore (W) Self-Luminous Light Sources CUSTOM DEVICE:

YES X

NO 11-1 7 NUREG 1556, Vol. 3 (draft)

I I

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) t h NR

• • • -D ***-E DATE.1 PAGE 2 OF 2 DEt! ICE TYPE:

Smoke Detector / Gun Sight DESCRIPTION:

Provide a concine, basic description of the device and iE more than one model in registered, provide the G *'ferences between modelu.

REFERENCES:

The following nupporting documento for the Model ABC omoke detectorn/ gun nights are hereby incorporated by reference and are made a part of this registry document.

'a applica tion da ted December 25, 0000, with enclosurea thereto.

'a lettero dated July 4, 1776, and December 25, 0000, with enclosuren thereto.

• a faculmiico dated July 4, 1776, and December 25, 0000.

ISSUING AGENCY U.S. Nuclear Regulatory Commission Date:

Reviewer

___Name of lot reviewer Date:

Concurrence:

Name of 2nd reviewer NURl!O 1556, Vol. 3 (draft) 11-1 8

sw

-i...

APPENDIX l ASSIGNING REGISTRATION CERTIFICATE NUMBERS e

i se P

Appendix I: Ass;gning Registration Certificate Numbers Fach registratien certificate has a unique registration number. The registration number consist of either 10 or 11 characters as descritsed below:

e NR-XXXX-D-YYY-S Agency Code (NR): A two-letter abbreviation of the agency issuing the certificate. All certificates issued by NRC have NR as the Agency Code.

Vendor Code (XXXX): 6ach vendor -(unufacturer or distributor) is assigned a unique three-digit number (the number mcy be four-digits). The vendor code used for the registration certificate number will be the vendor code for the distributor. if the company is out of basiness or no longer has an active registration certificate, the vendor code will between 800 and 1000 or between 8000 and 9000. The SSSS maintains the listing of vendor codes and issues new vendor codes.

Source / Device Code (D): A one-letter code which indicates whether a registration certificate is for a sealed source (S), a device (D), or (A) associated equipment.

Unit Number (YYY): A separate series of three-digit numbers assigned to registration certificates for each vendor. These numbers are assigned in sequential order starting with 101 for active registration certificates and starting with 801 for inactive registration certificates. A new registration for an existing vendor is assignud the next available unit number. The issuance of unit numbers is typically controlled by the agency that regulates the vendor.

License Code (S): Th:s is a one letter code which indicates how the source or device has been registered. "S" indicates it may only be useu by specific licensees, "G" indicates it may only be used by general licensees, "B" indicates it may be used by both mecific and genaal licensees, and "E" indicates it may be used by persons exempt from licensing, n

1-1 NUREG-1556, Vol. 3 (draft) l_

ta APPENDIX J LIST OF APPROVED WELL LOGGING SOURCES

7_---__..-_

6 I

. E I

5 Appendix.)U ust of Approved WeH.ogging Sources i

?

D

/,..a *se.,,\\

umiso staffs

.[

S NUCLE Ali REGULATORY COMMIS$10N.

nase.necto= o c mes y, g

'_g......

m e. at -

TO:

.All elell Logging Licensees

.y SutJECTI STATUS OF WELL LOGGING SOURCES In a memorandum dated August 10 1989 we informed Nuclear Regulatory Comission (NRC) well logging IIcensee,s of 3 tosporary generic esemption published in the F riR 1 r on July 25,1989 (54 FR 30643). The

- generic esser'tlen en e we ogging licensees from the requirement to use only Sealed sources that meet the prototype testing requirement spectfled in 10 CFR Jg.41(a)(3). The exemption applied to (and allowed the continued

~ use of) well logging sources that meet certain alternate prototype testing-criteria.

i 1

. The notice indicated that the enesotion would remain in effect until NRC published its final findings in the F r 1 Realster. Thus far MRC has been unable to initiate this action a higner priority activittest

- however, NRC now anticipates comencing this task in the naar future.

I Included in the memorandum with the F r 1 Reefster notice were three enclosures that listed various seale e moesis common to well logging

-and identified their tuttability for continued use in well logging operations.

There have been a few changes to the lists since first transattted. There are a few sources which we have determined meet the criteria specified in in

.10 CFR Part 39, and have added the sources to the approved list.

r

' Enclosed are the three enclosures which have been updated on a one-time-only basis to show the apparent current status of known well logging sources.

' lists those source models which appear to meet Section 39.41 requirements and are approved for continued use. Enclosure 2 lists those source models whose conttrded use is authortred under the temporary generic exception. Enclosure 3 lists those pourre models that do net meet the requirements of Section 39.41 or the generic esemption. When a sealed source is contained (and normally stored) within a device (logging tocl), the sealed source manufacturer and model number is shown below the entry. When NRC has been able to determine that a sealed source model was manufactured / distributed

=

by another company, or more than one model designation may have been used, this information is shown in parentheses below the entry. Neutron generators are

. shown by the designation "Nu GEN." An asterisk (*) indicates that the source is used within the' logging tool's electronics package.

i a

J-l NUREG-1556, Vol. 3 (draft)-

l

~

~

l i

NOV 1 Jr

<2 We do not intend to update these lists in the future. Due to the time which has passed, we believe that all questions concerning sources Icentified cn the unapproved list should have been answered. Ar.y rew well logging source introduced by source manuf acturers must be cestgred to meet the criterte specified in 10 CFR 36.41. Therefore. It will not be necessary to update the list to include a new source, as the 14RC or Agreec.ent state registration sheet for the source will indicate that use of the source in well logging operations is acceptable.

If you have any questions pleasecontactTorreTaylorat(301)4920611or J. Bruce Carrico at (301),492-f434

~.

w John E. Glenn, Chief Medical, Academic, and Cosinnercial Use safety Branch Civision of Incustrial and Medical micleer safety, NMss inclosurest As stated NUREG-1556, Vol. 3 (dran)

J-2

WELL LOGGING SEAlt0 SOURCES APPROVED UNDER PART 39 REQUIREMENTS MANUFACTURER g

AMER $ HAM CORPORATION AMN.CYn (n = 1 to 14)

AMER $ HAM CORPORATION AMN.CY1 AMER $ HAM CORPORATION AMN. pen n = 1 to 4)

AMER $ HAM CORPORATION CDC.CYn n=2to12)

AMERSHAM CORPORATION CKC. con n = 2 to 12)

AMER $ HAM CORPORATION CKC.800 SERIES AMER $ HAM CORPORAfl0N CYN. con (n = 2 to 12)

AMER $ HAM CORPORATION VD(HP)

(GAWA INDUSTRIES, GEN:RAL NUCLEAR)

AMER $ HAM CORPORATION CVN. CYP ANADRILL, INC.*

SGS-AA,5G5-8A, OR SGS-CA 150 TOPE PRODUCTS MODEL 274 SEALED SOURCE COMPROBE, INC.

1203 DENSITY PROBE GAMA INDUSTRIES MODEL VO-HP SEALED SOURCE GULF NUCLEAR, INC. MODEL VL-1 $EALED SUURCE 0:ES$ER INDUSTRIES INC. (Nu GEN)

C 58301, C-107298 E.I.0UPONT ;E NUMOURS & C0.

NER 571 (NEW ENGLAND NUCLEAR)

GEARHARTINDUSTRIES,INC.(NuGEN) 013-1004-000 GENERAL ELECTRIC. CO.

GE(N)-Cf-100 SERIES GULF NUCLEAR, INC.

VL-1 (NEEI)

GULF NUCLEAR, INC.

71-1 (NEEI)

(NEEl-AM8E-71-1)

KAMAN SCIENCES CORPORATION fNu GEND A-3061 KAMAN SCIENCES CORPORATION INu GENl A-320 KAMAN $CIENCES CORPORATION I Mu GENS A-520 KAMAN SCIENCES CORPORATION INu GEN)

E-M10 AND E-3020 MON $ANTO C0., DAYTON LABORATORY H245258(NSR-M)

MONSANTO C0., DAYTON LABORATORY 24113 MONSANTO C0., DAYTON LABORATORY 24154-C MONSANT0 C0., DAYTON LABORATORY 24174 MONSANTO C0., DAYTON LABORATORY 24181 MON 5ANTO CO., DAYTON LABORATORY 24183 33 NUREG lS56, Vol. 3 (draft)

i WELL LOGGING SEALED SOURCES APPROVED UNDER PART 39 REQUIREMENTS (cont'd)

MANUFACTUDER WODEL P.A. INCORPORATED H-245258 (NSR M)

(MONSANTO)

P.A. INCORPORATE 0*

P 194693 SCHLUMBERGER OWG H-115686 (MONSANTO,NUMEC)

SCHLUMBERGER OWG H-142108 SCHLUMBERGER OWG H-239681 SCHLUMBERGER WELL SERVICE 5*

P-194693 SCHLUMBERGER WELL SERVICES NSR-R PA2A,(OLD:PA28, PT2A, PT28, PS2A, UNC NUCLEAR INDUSTRIES PS2B SM-100)

E.I.0UPONT DE NUMOURS & CO. (NEN) MODEL 478C SEALED SOURCE US DEPARTMENT OF ENERGY SR-CF-100 SERIES NUREG-1556. Vol. 3 (draft)

J-4 m

WELL LOGGING SEALED SOURCES APPROVED UNDER THE GENERIC EXEMPTION MANUFACTURER MODEL COMPROBE, INC.

1203 DENSITY PROBE GULF NUCLEAR, INC. MODEL CSV SEALED SOURCE COMPROBE, INC.

2103 DENSITY PROBE W90. INDUSTRIES (GAlfiATRON) MODEL AN-HP SEALED SOURCE E. I.D'.'PONT DE NUMOURS & CO.

NER-572, NER-582 (NEW ENGLAND NUCLEAR)

GAMMA INDUSTRIES CS-1000(HP)

(GENERALNUCLEAR,INC.)

GA MA INDUSTRIES GN!-NB(HP)

(GENERAL NUCLEAR, INC.)

GAMMA INDUSTRIES NB(HP)

GAMMA INDUSTRIES NHP-A #

(EENERAL NUCLEAR, INC.)

GAMMA INDUSTRIES WLG-1 GAMATRON, INC.

AN-HP (NUCLEAR SOURCES AND SERVICES, INC.)

GAMMATRON, INC.

AN-HPG, RN-HP (NUCLEAR SOURCES AND SERVICES, INC.)

GA MATRON, INC.

OA-20 (NUCLEAR SOURCES AND SERVICES, INC.)

GAMATRON, INC.

DA-5 (NUCLEAR SOURCES AND SERVICES, INC.)

GAMATRON.-INC.

GT-GHP (NUCLEAR SOURCES AND SERVICES, INC.)

GULF NUCLEAR, INC.

AMBE-71-2A (NEEI)

GULF NUCLEAR, INC.

C-73-2 (NEEI)

GULF NUCLEAR, INC.

CS-2 (NEEI)

GULF NUCLEAR, INC.

CSV (NEEl)

MONSANTO CO., DAYTON LABGRATORY 24112 MONSANTO CO., DAYTON LABORATORY 24120 PARKWELL LABORATORIES, INC.

PL-104 (USNUCLEAR)

J-5 NUREG-1556, Vol. 3 (draft)

KNOWN SEALED SOURCES NOT APPROVED FOR USE IN WELL LOGGING MANUFACTURER MODEL AMER $ HAM CORPORATION CD CQ 5987 AMERSHAM CORPORATION CDC.800 SERIES (.801TO.811)

DRESSER ATLAS B89596, B89597, B89598 FR*NTIER TECHNOLOGY CORP.

100 GAMMA INDUSTRIES GNI-OL-4 (GENERALNUCLEAR,INC.)

GAMMA INDUSTRIES GNI-NB S-5.0 (GENERALNUCLEAR,INC.)

GAMMA INDUSTRIES NB-$-1, NB-S-20 GAMMA INDUSTRIES PL-AMBE-2.7 (GENERAL NUCLEAR, INC.)

GANMA INDUSTRIES RC-1(HP)

GA)NA INDUSTRIES S-14 GAM 4ATRON, INC.

GT-G (NUCLEAR SOURCES AND SERVICES, IkC.)

GENERAL NUCLEAR, INC.

GNI-C(G)M-5 GULF NUCLEAR, INC.

C0 50 (NEEI)

GULF NUCLEAR, INC.

CS-50 (NEEI)

GULF NUCLEAR, INC.

TG-1 (NTEI)

GULF NUCLEAR, INC.

72-CO-200 (NEEl)

HASTINGS RADI0 CHEMICAL WORKS CS-l!!-A-100 ICH PHARMACEUTICAL. INC.

373 (USNUCLEAR)

ICN PHARMACEUTICAL, INC.

374

~

(US NUCLEAR)

ICN PHARMACEUTICAL, INC.

376 (US NUCLEAR)

ICN PHARMACEUTICAL, INC.

3146 NUREG-1556, Vol. 3 (draft)

J-6

i KNOWN SEALED SOURCES NOT APPROVED FOR USE IN WELL LOGGING (cont'd) i

$VFACTURER MODEL

!$0f0 PES $PECIALTIES C-0037 LFE CORPORATION C5-15 (TRACERLAB)

MINNESOTA MINING AND MANUFACTURING 4F65 MINNES0TA MINING AND MANUFACTURING 4F6H (REDESIGN OF MODEL 4F6B)

MINNESOTA MINING AND MANUFACTURING 4F65 MINNES0TA MINING AND MANUFACTURING (P6F MINNESOTA MINING AND MANUFACTURING 4P6U MINNESOTA MINING AND MANUFACTURING 4P6W MONSANTO CO., DAYTON LABORATORY H 142525 (SCHLUMBERGER WELL SERVICES)

MONSANTO C0., DAYTON LABORATORY H-207947

($CHLUMBERGER WELL SERVICES)

MON $ANTL C0., 0AYTON LABORATORY MRC MONSANTO C0., DAYTON LABORATORY MRC-N-SS-W-AMBE(R)

MONSANTO CO., DAYT0;l LABORATORY NS WELEX HONSANTO C0., DAYTON LABORATORY 2410 MCNSANTO CO., DAYTON LABORATORY 24154-B NUCLEAR MATERIALS AND EQUIPMENT CORP.

NUMEC-AM. 62, 63, 100, 123, 154 NUCLEAR MATERIALS A'l0 EQUIPMENT CORP.

NUMEC DWG. Il-B-208 PARKWELL LABORATORIES, INC.

PL-AMBE SCHLUM8ERGER OWG H-1061850 SCHLUM8ERGER OWG H-123515 SCHLUM8ERGER OWG H-123837 SCHLUM8ERGER OWG H-218733 SCHLUM8ERGER OWS X-Il3176 WELL RECONNAl$ANCE, INC.

10411 Ar4ER$ HAM /SEARLE MODEL X.154 SEALED SOURCE W51 A4794 J-7 NUREG-1556, Vol. 3 (draR)

NRcfOMM 335 U s. NUCLEAR RhoVLAToRY cOMMi$btON 1 REPORT NUMBER pem lAssened by N,4C, J.ed Vol., supp, Rev.,

NRCJ 1102 and Addendum Numbers, W any )

8**

BIBLIOGRAPHIC DATA SHEET

' <sa **w*oas ca me a*rw)

NUREG-1558. Vol. 3 7111LE AND SuttiliLE Consohdated Guidance about Materials Licenses:

, Applications for Scaled Source and Device Evaluation and Registration 3-DATE REPORT PUBLISHED I

YtAR MONTH Dr:ft Report for Comment

_ September 1997 4 FIN OR GRANT NUMBER b t,u1 HOR (S) 6 TYPE OF REPORT J. Lubinski. S. Baggett D. Broaddus, M. Burgess, E. Compten, K. Randall, T. Rich, B emith Dr dt

7. PERIOo COVERED (sarJus,ve Dews /

8 PEeJ ORMING ORGANilATION. NAME AND ADORESS (if NRO, prowde Dwam. oAs or Reg,on. U S Nucamar Reguwory Commsse. and man acess. dcontrecfw.

prowne none end men ocness I Offic] of Nuclear Material Safety and Safeguards Division of hdustrial and Medical Nuclear Safety U. S. Nuclear Regulatory Commission W:shington. DC 20555 0001 9 SPONSORING ORGAMIATION. NAME AND ADDRESS pf NRc, tysu Same as abow', dcuntractor, prowde NRC Dwam. oNo or Regm U $ NucAsar Populatory Comnsam erittme M ainess)

S:me as above 10 SUPI'LEMENT ARY NOTES 11 ABSTRACT (200 monss oriens)

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as desenbed in NUREG-1539 and draft NUREG-1541. NUREG 1556, Vol. 3, is int:nded for use by applicants, registrants and NRC staff in applying for anti evaluating applications for registration of sealed sources and devices The final version of this document is intended to supercede guidance provided iri NUREG-1550, "St:ndard Review Plan for Applications for Scaled Source and Device Evaluations Regulatory Guide 10.10," Guide for the Pr:paration of Appi cations for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material," and Regulatory Guide 10.11," Guide for the Preparation of Apphcations for Radiation Safety Evaluation and Registration o' Sealed Sources Containing Byproduct Material."

U^*^Nk"'MA N I 12 KEY WORDS/00SCRIPTORS (Det morce or arveses et at we assst researchen a meanno me remvt J unlimited Scaled Source. Devica, Registration Registration Certificate, Sealed Source Evaluation, Device Entuation,10 CFR 32 210,10 CFR 30 32 u secumTv ctAmicanoN (Th s PageJ unclassified IT!ns Report) unclassified 15 NUMBER OF PAGES to PRict

- NHL 8 Om *n Q Mt TWorm en emmi,y produced by EMe Federal Forms W

k Printed on recycled paper Federal Recycling Program

?

s o

a

+

g Ag N;

w

.8 4

y (5

(

l' rk R (k

.f, s$ g sa

> $n s,

j u ; ;4. -

1. 1. _

,s

.LL

L- \\;

. 4 -' Q A J

i 3

y ff 2 y fk e

1 hhI 7

ghh:f'

}l N hhh l'

i 4)l3f' ']:

+

. a c

nsw% ph,i; ue 8

Qu Q p

g Tu 4

-W ap m

.Mt 8

f fj mdh i ;y, j (.

4l}

%y

$3]fff!:khg g g g[ $[f a,4.g g[

-}

a g

ggnp+ ~g LJghpd$$,$k@i$m S4sd 1 Id c

.i 1

l

n.

}

e.

~

_ FIRST CLASS Mall D

iUNITED STATES POSTAGE AND FEES PAJO.

NUCLEAR REGULATORY COMMISSION

'USNRC' t WASHINGTON, DC 205554Xmt N Na W lT PENALTY FOR PfWATE USE, $300 S

A 4

• • T

-r-w s-q s.

.6 w

'. 's P

e

.a

,i i

i

')

Mf y

[#

'N s

4 7

.c e

f 2 '.'"'

.y g

,1 i. '

3

y ~

a

,qp e

a....

a

+... r#k --

?..._1 ge t-

• )

• hl',_

= g; t

+

.nx

~,

x

. x,,.

..a?

...lJ s

~

- y

-v p

. 'L. s-

+

+

^

_1y y

4.g

..-a y

f l

ll-S o^

e

<1

.~ -

~.

L.

.'