ML20216H506
| ML20216H506 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/1999 |
| From: | Abbott C NRC |
| To: | Mattsen C NRC |
| Shared Package | |
| ML20216H047 | List: |
| References | |
| FRN-64FR40295, RULE-PR-170, RULE-PR-171, RULE-PR-30, RULE-PR-31, RULE-PR-32 AG03-1-012, NUDOCS 9910010404 | |
| Download: ML20216H506 (49) | |
Text
ICatherine M'ttsen -_OCFO Revhw of. Proposed Rulimaking Prck'ge 'Pitts 30_,31,32,17_D,& 171...G*ntrally Lic nsid DivEagt"1]
AGo%
P0R From: Carol Abbott To: Catherine Mattsen Date: Wed, Mar 24,1999 6:44 PM
Subject:
OCFO Review of Proposed Rulemaking Package " Parts 30,31,32,170,& 171... Generally Licensed Devices.."
NOTE TO: Catherine Mattsen, NMSS/IMNS OCFO has reviewed the rulemaking package entitled " Proposed Rule: 10 CFR Parts 30,31,32,170, and 171 --- Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material" that amends the regulations governing the use of byproduct material in certain measuring, gaging or controlling devices.
You have addressed our concerns and incorporated OCFO-recommended changes into the " Regulatory Analysis". We therefore concur in the package.
If you have any questions, please call me at 415-6034.
Carol Abbott REF:
DBA-99-090 OC-99-121 DBA File: NML-1.1.7 CC: Diane Dandois, James Turdici, Jerry Elder, Kare...
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g' NUCLEAR REGULATORY COMMISSION IBAsMINSToti. B.C. SIBI540M
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The Honorable James M. Inhole, Chairman Subcomrrettee on Cloen Air, Wadends, 4
Private Property and Nuoleer Safety Committee on Erwinmment and PutHic Worke United States Senate
-Washington, DC 20510
Dear Mr. Charman:
Encloeod for the irWormaton of the Subcommittee is a copy of a Notice of Proposed Rulemsking to be published in the Eghal Hegalet soon. The U.S. Nuclear pulatory Commisolon (NRC)
,' ) require the .setoln is proposing to amend 10 C. FR Parts 30,31,32,170. and 171 t . ,
generaf ( "+G );; register certain devions that they have reoolved for use uhbtv under apgenere "d b heens/ A add a registration fee. NRC plans to institute this repletration system'
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devices using consin q of specific are primarty usedin commeraal Wg- I and industle! --- ed r* would ateo revise j
requiremente fortra , reportmg. recordkeeping pertaining to those generallylicensed devices.
NRC has obserd a number of instances in the past where generally licensed devloes have not been pmpedy handled or disposed of. This amendment would allow NRC to better account for i
devices that have been distrbuted for use under the general licente and thereby reduce the 1
potential for incidents that could result in unnecessary radiation exposure to the pubhc as{
t contaminston of propedy. Thit Change will have no adveres Imps 0t on the heellh and eefety of workersfor the pubic and is not expected to impose a significent burden on lloonoces.
sme==ly.
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MAR 24 '99 03:47PM P.15/15 y fCYt Ok ,
The Honorable James M. Inhole, Chairman Subcommdtse on Cloen Air, Wetlands,
. > Private Property and Nuclear Safety J Committee on Environment and Public Works
- United States Senate' Washmgton,DC 20510 peer Mr. Chairman
V Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemeldng to be pubhehed in the Federal M soon. The U.S. Nuclear Regulatory Commiselon (NRC) f is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to explicitly require that certain general licensees register certam devloss that they have roosived for use under a general
'( license and to add a registration fee. The NRC' plans to inattute this rogstradon system for deviose using oortain quangiles of specihc radionucildes that are primarily used in commercial and industrial app 5cathms under an earlier proposed rule. The enclosed rule would also revles requirements for transfers, esorees, repor$ng, recordkeeping, labohng pateining to these genmenylicensed devioss.
NRC hee observed a number of instances in the past where generally licensed devices have not been property handled or droposed of. This amendment would allow NRC to better account for devices that have been detributed for use under the genereillcense and thereby reduce in potential for incidents that could result in unnecessary radiation exposure to the public as well as contaminston of property. This change wNl have no edverse impact on the health and esfoty of workers or the pubus and is not expected to impose a signWicant burden.on nooneses.
Sincerely.
Dennis K. Rathbun, Director omos of Congroselonal Affairs l
Enclosure:
Idemicalletter sent to:The Honorable Joe L Barton i Federal RANotice oe: sonetor sob or.h.m DISTRioWTioN-sood 8dendeWS opeland CRMessen WW pages Det ofr.M oAosal Gle ,iT;:n**aL=oll>I , ./
I W I DNMES I OCA I oPPICE Reesses I nethemes I o:sems Hoh enAnni cameson PHuemen W ennd cPeseneSo DNAaseun at 40 t W if 1B "" L _/_ 40 / M a DATE I /
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t%R 24 '99 03id7PM P.1449 ace, UNITED STATES a ' NUCLEAR REGULATORY COMMISSION
- WASHINGTON, o.C. memeeM
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Demis K. Rathbun, Director l Office of Congressional Affairs EncJosure:
_ Federal Register Notice 4 cc: Senator Bob Graham
rm 24 '99 03: dr,Pt1 p, n,3
' The Commh . 10
- 1. Draft guidance iof Imenses for dstribubon to poneral licensees wm be put$shed for comment. A brief appendix for use in providing guidance to 10 CFR 31.5 genem! ,
remnamesis MM. (4techme* B)
\
William D. Travers Executrve Drector for Operations Attachments;
~/1. Ana9 sis of Fee structure optam
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- p. Draft FedermIfEalster
[3. Resource Estimate for General leense Prograrn f g 4. Impa Convertin 0 Porinble MnistKGauges to Mred [
Generally Licensed Rennurces and Time j
' V 5. Draft Regulatory Analysis -- ;
V6. Draft Congresesonal Letters
- h. Drstt Proes Release .
V 8. Draft Form XXX - Transfers of Industrial Devices Report
- 9. Drott NOREG-1556, Vol.16. Consolidated Guldence About Materials ;
Lloonees: Program. Specific Guldence About General License Distribubon Licenses i
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fW d4 'W B3:46PM p.12/15 The Commisekmers 8
- j. Draft guiderce for leoness for dstribution to Osmeral licensees will be pubbshed for commerit, A brief appendix for inne in provdng guidance to 10 CFR 31.5 general 'f licensees is included. (Attachment 9)
Wi#iem D. Trevers lixecutive Director for Operationn Attachments:
- 1. Analysis of Fee Structure Opbons
- 2. Draft Federal Ramster Notce
- 3. Rosaurce Eshmets for General Ucenee Program
- 4. trPM c% Portable Mossture fed GenereRy L.conced Resources andTmelanoj
- 8. Draft Regulatory Analysis ~
- s. DrsR Ce.Fz::{ ; Letters
- 7. Draft Press Release ,
S. Draft Form XXX - Transfers of Industrial Dewoom fileport l
- 9. Draft NUREG-1566, Vol.16, Consolidated Guidance About Meterials Licenses: Program-Specific Guidance About General Ucense Distelbution UconsecoocuwwTmeeveneaeervem l
RECORD NOTE: A draft copy of the proposedninal rule was sent to 010 for1r formation on .
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1 198: The Commissioners f:BQM: William D. Travers Emscutwe Director for Operates
$UBJECT: PROPOCED RULE: 10 Cf% PARTS 30,31,32,170, and 171 -
'HEQUIREMENTS FOR CEMTAIN GENERAll.Y UCENSt:0 INDUWl RIAL i DEVICES CONTAINING BYPRODUCT MATERIAL * !
l PURPOSE:
To request Commission approval of a proposed rule that would explotty require general licensees who possess certain dewees containing byproduct materiello register their devices,
. and add other pnmoions that are intended to impewe the accountabmty of generai !
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43 Enk kane f {.s g? 1 U)ork n. lM' B&f,KGROUND- 1 Devices containing radcactive meterial generaly hoensed under 10 CFR 31.6 have not shup
' been diepceed of, or handled properly. On a number of occasions, this has resulted in !
unnecessary radiation exposure to the pubhc and contarranation of property. The pg concluded that more frequent and timely contact between the general licenses puid NT ')
M usem remedy these protnoms. On December 27,199 (56 FR 67011 NRC pubhshed a proposed j v
rule this issue. The pepposed rule would required generallicensees under
(, die 31.5 to prowde information at NRC's request. This proveon would inve provided the regulatory basis for the repstratkm of generallicecsees possessing these devices. The (t
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rw a f w . e wm P."Fis The Commisseners 2 proposed suie also included addlional requremetds in 10 CFR 32.51a and 32.52 for the apocNic licensees who marwfacture or iritish transfer these devices to the generallicensees.
A final rule was not w' nplemented because the resources needed to properly ir/plernent the proposed rule werelacking.
CONTACT: Catherine Matteen, NMSS/IMNS (301) 415-6264 d
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tw e4 t> nu.4eM t p.4/15 The Cornmieskners 3 in July 1995, wllh anslatence frorn the Organizaton of Agreement States, NRC formed a workms group to evaluate the leeues related to the loss of control of generaby and speal6cepy leoensed sources of i+ Ddi. This NRCfA.,. M 81ste Working Group submitted a final report to NRC conoeming its evalueekm. On October 18,1996, the staff provided its evalumbon of the workin9 group recommendations in 8ECY 96-221. This report wee published as NURE31881 in October 1996. On November 13.1996, the etsff briefed the Commission on its prehmmary views of the NRC/ Agreement State Worldng Group's recommendsbons, ,
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3 in an Aprt 13,1908. Staff Requirements Memorandum (iiRM). responding tD SECY-07-273.
" improving NRC's Control Over and I.acensees' Accountab9ty for Genendy and SpeclNcally 1.icensed Devees.* the Commiseen directed the eleff to terminate the 1991 rulemeleng except
- for the provmons that would enable NRC to request information from certain general licensees to pronde the reguietory beels for a regstration program and to renotice hose porters of the )
' 1991 pmposed rule for public comment. That proposed rule notice was prended to the Comminaion in SECY.98-199 epproved by an SRM of October 23.1998, and putsched on December 2.1998 (83 FR 96492). The April 13,1998. SRM slao directed the staff to develop, in a subsequent rulemaldng. a registration and fotow up pmeram for generaby hcensed eeuroesMovious edenb6ed by the NRC/ Agreement State Worldng Group in NUREG-1551, to assoas fees to meet general licensees, and to incorporate requiremente for the permanent lebeEng'aiacurceeMovices. The staff was eleo o the poseilmiles.
,, l advantages, and disadvante0ee of various fee such as pro raeno me feet .. per (Ilseder aEding scale) or per and provide recommendatiorm to the Commission '
an (to determine he extent to which applicebon of the 6 mall businees rule will afled the fees.
The anchels of fee optens (Attachment 1) and flis proposed rule (Attachment 2) respond to pp e a, d.e.oism a of me SRu).
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The Commisoloners 4 in the Aprilif,1 (item 6), the Comtression also directed the staff to irnpiement an
.nf_em.nt .mt _ . ohm t, - .n. - -
1 eddresesng the amnesty was presented to the Commiseen in SECY48 303 and published March 0,1000 (84 FR 11508). The Commission Indiosted that the inoroesed alvtl penaislee should be significantly greater than the ogets of propor dispoeal or transfer of a souses or dowlee. The NRC/Agreernent 8 toto Working Group recommended evil penefties in the range
[ 2 to 3 times the' cost of authorized deposal, types of sources and dowoes, the ste# is the estabilehment 7 d I _ c._ of base old ponelty for lost fA , sis. coo,and s4s,ooo. The be eidponeny uisis sourcee g waddbe asquesed by the olvil pensky esquetment fastere in the current Enforooment policy. In acidigen, in accordance with Geotion Vll.A.1(g) of the current Enforcement Poecy, enforcement discretion ]
oould De used to inoroese the old pensity amount or to assess a olvt pensity where appGoeden i of the esguetment festore normally would eseutt in zero civil penalty. Under the current Enforcement Policy, the beso civt penalty at Severity Level i for a general Weense le 85 .
m.o. _ _ _ ,,so_.e-- - .oed, p.e.g _,e times the everage oost of proper trenefer or disposal of the sourpos or devices. A civil ponelty e ;
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ot se.o0e io . en.rai r,o e e.r i.e. or improper ep.e.i e be .,,,.dm.to.y eign(p times greater lthan the base civil penalty for other types of Swerty Level I violations. h staff 1 further considering these iseuse and we meno a f6nal rooommendeten to the commiselon
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and implement the Commloelon's dooielen concurrent with the effective date of the final rule, as perthe April 13.1996, 1
l m< eu w e.v.uwn P.6/15 l
The Commissioners 5 Item 4 of the April 13,1r96, SRM addressed a materials risk review. Information on that action was prwided to the Commletion in SECY 99 062, dated March 1,1999. Item a addressed continued efforts on'an orphan source program. This subject was discussed in SECY-99438, dated February 3,1999.
Item 7 of that SRM directed the staff to prowde an estimate of the resources needed to fully support this enhanced general license progam. The stafI has developed the table in i Attachment 3. The table hcludes the resources needed to develop and fully support the
{ GO registration program for the approximate 6000 general licensees identified in the SRV well as other aspects of the enhanced nanami @nse program. The staff notes that the resources identifiedin the table are included curre ( ~ budget and are being addressed in the 'h 1.c.a FY ;C1 budget.
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rp et in addition, Attachment 4 prov4es a partial response tu a December 21,1998, SRM responding to SECY-98 232. In that SRf( the Commission directed the staff to estimate the resource impact of adding approximtstely 5000 portable moisture denstty gauges as generally licensed devices to the"poo ubject to the proposed re9 1stration program and whether the program's trneline as described in SEGY.96-199 would be negatively impacted.
DISCUSSIQh!
The proposed prcMslons delineating an annual registration requirement are essentially consistent with the plans for the registration process discussed.in the first of these proposed rules. The criteria for determining which devices would be included in the registration program are those recommended by the working group. As part of the registration program, licensees 6
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r rm g4 'w es:asmi p.pis The Commiseloners 6
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wth be saked to venfy iryforrystiort concoming the 'stentificaten of cleweet, accourrlat2ty for the a dowoes, the percors resensible for compliance with the regulatione, and the disposition of the dedone. The staff solimates cat approsemotely 9000 noneral licensees would be requ; red to provide registradocilntormaton annuesy. As directed by ow commiselon,'the proposed rule wrwM elmo add a registration foe.
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The pt.= ni ede wov'a require that general iconeses under 1.5 sopoint an individualto be responsible for ervuning day-to day comc6ance with the regulations. De dlstritev of the !
genere#y licensed product warald have to obtain the nome and phone number at this person from its customers, rather then almp>/ a cortact, and provide this informaton to NRC orthe Agreement State 'm quarterly trenefer reporte. For those respetering devices, closmetion on this responerie Individuel wene be updated through the re01stration procoes. The sonal number of devees would be added to the informadon reponed in cuarterly trenefer reports and to reporte of tienefers by general Econeses oo '5st int 9vidual devices can be tracked. Additionel labeling would be required to beHar aneure that devlees can be identified as contohing radonctivity and can also be tremed back to the responsible partyin the event of lose of control. There are some ackStional previolone, not erMressed in the NMC-Agreement State recom eleo intended to inprene the mooountability of devices generally licensed under 31.5 and to clartly the ... ' 1.i pertoniing to su generally scensed products contelning byproduct metenal. ,
l The pmposed rule is ineended to baner ensure that costein general lloenoese are aware of
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epphoeble requirements and een account for their devious. Communioedon with general licenseee, accompinehed primarily through repetration. would provide NRG assurance of licensee accountabimy " The staff believes that if general licensees were more aware of their
. .;-x-2"t. they would be more likely to comply with the requirements for peuper handling y
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The commiamianers 7 and deposel of er*rauy G beenmed dewes. This would reduce the potenbal for incidents that i
could result in unnecosesry redation expneure to the public and contaminabon of proposty.
The p ci-:::I rule is also intended to hattar nurm NRC and the Agreement States to keep track of general licensees, inclueng trackin0 of spanWin devices Tracidng the general lesensees is important so that they can be contacted and innpacted as appropriate. Tracking will eleo allow devices to be traced book to the owner in the event tout they have been found in inapprepaste loostions or it a generic defect le identified in a group of devloss.
The pie;-:::I amendments were provided to the Agreemant Ataten ring its w.. . - '- the use of the NRC Techmeal Conferenoa Wahalle and nodhcation to the I
cf its . "' 'i:f. Input was reeowed fotowing the fitet pustin0 through docussions at an
?bhTat State meeting in October of 1998. The second posting was also avabatne to the W
publie. A ruwes of evailabdity was publehed December 31,1998 (83 FM 72216).
nssoungss:
De secourses needed to complete this action are in the current budget.
D COORQllMLIlON-The Offlee of the General Counsel has no legal objection to the proposed rulemaking. The Office of the Chief Financial Olticer has revowed this paper for resource impiscations and has no ahW The Office of the Chief Information Othcer has reviewed the proposed rule for interrnston technology and information managemant implicatene and concurs in it. However,
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WJt 24 *99 03:4,m P.9/a5 i The Commeeioners 8 the proposed rule would amend information coNectkm requirements The package requesting 1
revow aM approval of the amended information collecten requirements must be recewed by the othee of " 'g4Ta.^.t and Budget no later then the date the rule is pubhshed in the ederal i gaggg.
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RECOleMiNDATIQldGl: ;
I That the Commisskm:
- 1. Approve the notice of proposed rulemaking (Attedwnent 2). p l
- 2. Gggg that this rule, N edopted, win not have a significant impact on a substantial number of emet enthies, to satefy the requirements of the Regulatosy Flexibility Act.
5 U.S.C. 506(b). -
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- 3. Hats:
- a. The rutomaking will be puMshed in the Federal Register for a 7!Wiey pubHe Period. --
- b. This rule has "been reviewed by the Agreement 9tates.
- c. Neither an cr i.w T.ertal impact statement nor an environmentel essessment has been
>7 prepared beoeuse the provisions in this proposed rule are the typ/of accons descWxs in the estegertoel emolusions 10 CFR St.22(c)(1) t%5 (3).
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= ' a ao awww c1rares r nw r e s sc.n snnua. 1ss. <ws car osas e. s s MAR 24 .'99 03:46Pf1 P.10/15 The Comminasoners 9
- d. A draft regulatory analyers has been prepared and will be available in the Put#c Document Room (Attachment 5).
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- a. The appropnete Congressional committees will be inforrned (Attachment 6). I w l
- f. The Chief Counsel for Advomey of the Amau Buscens Adminstration we be informed of the certtfication regardmg ecsww.t impact on small antities and the' reasons fof it as required by the Regulatory Flexibility Act.
- g. The proposed rule would amend information collection requsements that are subject to the Paperwork Reducten Act c61995i (441J AC. 3801 et seq.). These requirements will
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be forwarded to the Office of Mana0ement anti Fkriget for apptrwat
- h. A draft press rolesse will be issued by the Othes of P: Alie Affairs when the proposed rulemaking is 10ed with the Office of the Federal Register (' Attachment 7). h*2
- i. An optional Form XXX will be made atullnble for distritxators' quarterly transfer reports.
(Attachment s) 0 f
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l Appendix J Review Checklist for General Distribution License Application (32.71?
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APPENDIX J j Review Checklist for General Distribution License Application (32.71)
ITEM 1: ACTION TYPE ACTION TYPE: ADMINISTRATIVE REVIEW:
[] New [] Current Guidance Used
[] Amendment [ ] References in Application Based On Current Regulations
[] Renewal [] All Attachments Referenced Included
[] Signatureon Application ITEM 2: LEGAL IDENTITY
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NAME:
ITEMS 2 & 3: ADDRESS l
LOCATION OF DISTRIBUTION MAILING ADDRESS: l ADDRESS: I l
ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION CONTACT PERSON:
TELEPHONE NUMBER:
J-l Draft NUREG - 1556, Vol.16
e ., l APPENDIX J l
ITEMS 5 & 6: MATERIAL TO BE DISTRIBUTED Item Isotope Maximum Quantity Per Purpose of The Prepackaged Unit Prepackaged Unit ;
List as Stated in Application Defined in 1-125 <10 microcuries Distribution for use under a 32.717 1-131 <1O microcuries GL of 31.11 C-14 <10 microcuries (in vitro test kits for non-H-3 <50 microcuries human /non-animal use only)
Fe-59 <20 microcuries Se-75 <10 microcuries MOCK I-125 <0.05 microcuries I-129 and
< 0.005 microcuries Am-241 YES/NO YES/NO YES/NO ITEMS 7,8,9 & 11: NOT APPLICABLE Draft NUREG - 1556, Vol.16 J-2 l-
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APPENDIX J ITEM 10: RADIATION SAFETY PROGRAM Issue Suggested Response Provided? Yes/No Labeling (32.71(c)) Submit an Actual Package Label that Contains the Following:
. The radionuclide and chemical form; A statement that the radioactivity does not exceed the limit indicated above for each radionuclide; The Radiation Caution Symbol Described in
{20.1901(a);
- The Words, " Caution - Radioactive Material,"
and "Not for Intemal or External Use in Humans or Animals;"
Label / leaflet Submit an Actual Package Label (Or (32.71(d)) Leaflet / brochure to Accompany Package) That Contains a Statement, or a Substantially Similar Statement with the Following:
"The Radioactive Material May Be Received ,
Acquired, Possessed, and Used Only by Physicians, Veterinarians in the Practice of Veterinary Medicine, Clinical Laboratories or Hospitals and Only for in Vitro Clinical or Laboratory Tests Not Involving Internal or External Administration of the Material, or the Radiation Therefrom, to Human Beings or Animals. Its Receipt, Acquisition, Possession, Use and Transfer Are Subject to the Regulations and a General License of the U.S.
Nuclear Regulatory. Commission or of a State with Which the Commission Has Entered into an Agreement for the Exercise of Regulatory Authority. (Name of Manufacturer)"
j- Label / leaflet Submit an actual package label (or leaflet / brochure (32.71(e)) to accompany package) that contains the 7 precautions to be observed in handling and storing such byproduct material.
J-3 Draft NUREG - 1556, Vol.16 Y _ _ _ _ _ _ _ _ _ . _
APPENDIX J Issue Suggested Response - Provided? Yes/No Label / leaflet Submit an actual package label (or leaflet / brochure (32.71(e)) .for to accompany package) diat contains directions on Mock I-125 Kits disposing of waste in accordance with s 20.2001.
Draft NUREG - 1556, Vol.16 J-4
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Appendix K Guidance for General Licensees
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APPENDIX K Guidance for General Licensees
- 1. What is a generally licensed (GL) device?
Generally licensed (GL) devices are devices containing radioactive material and are typically used to detect, measure, or control the density, level, or chemical composition of various items. Examples of such devices are gas chromatography (detector cells), density gauges, fill-level gauges, and static elimination devices.
Transmission Gauge Insertion Gauge C
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0 1 LLL Fill Level Gauge Density Gauge sw_e29snmg Figure K.1 Fixed Gauges. Certainfixednuclear gauges may bepossessed and used under the generallicense in 10 CFR 31.5.
- 2. What is a generallicensee?
A general licensee is a company or person who uses or stores a GL device and has received this device through an authorized transfer by the device manufacturer / distributor or by .
change of company ownership where the device remains in use at a particular location. A
, general license does not apply if a company or person receives a device through an K-1 Draft NUREG - 1556, Vol.16
- s APPENDIX K unauthorized transfer. If you have received a device through an unauthorized means, contact your regulatory authority immediately.
- 3. What is NRC registration of generallicensed devices?
NRC requires that certain devices authorized in 10 CFR 31.5 be registered each year.
Registration of the device is dependent upon the type of radioactive material in the device and the quantity of the radioactive material. See items 4 and 6, below.
- 4. Which GL devices are subject to NRC registration?
Devices that are subject to NRC registration are devices used and/or stored in NRC States that contain at least 370 megabecquerels (MBq) (10 millicuries (mci)) of cesium-137, 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60 or 37 MBq (1 mci) of americium-241or any other transuranic, i.e., element with atomic number greater than uranium (92).
- 5. How do I know ifI have a GL device?
If you have a device as described in 1. above, look at the device for any and all labels.
GL devices should have labels containing such words as:
" Caution-Radioactive Material"; "The receipt, possession, use, and transfer of the device are subject to a general license"; OR Identification of the radioactive material such as "5 millicuries of cesium-137" or "I mci of Am-241" Also, review any paperwork (such as manuals or brochures) that you received with the device. This paperwork can provide you with information on the radioactivity contained within the device and whether or not the device is subject to NRC regulations. If you are still unsure, call the manufacturer of the device for help. If the manufacturer is not available, call the NRC.
Other similar devices have not been authorized for general license distribution.
Manufacturers or distributors will notify their customers when such devices require a specific license. The customer should apply to the NRC or appropriate Agreement State for such a license.
- 6. How do I know ifI have a GL device that is subject to registration? I Usually the device manufacturer will inform you that the device you purchased is subject to
- the NRC registration requirements.- However, you could look at the identification of the s radioisotope and quantity of radioactive material listed on a label on the device. If the Draft NUREG - 1556, Vol.16 K-2
e .
i APPENDIX K device contains at least 370 megabecquerels (MBq) (10 millicuries (mci)) of cesium-137, 3.7 MBq (0.1 mci) of strontium-90, 37 MBq (1 mci) of cobalt-60 or 37 MBq (1 mci) of americium-241 or any other transuranic, then it is subject to registration by the NRC.
- 7. What are the requirements for a GL device?
GL devices used within non-Agreement States (refer to Figure K.2. for a list of non-Agreement States (also called NRC States)) are subject to the NRC regulations listed '
in 10 CFR 31.5. General licensees are required to appoint a responsible individual to know about the requirements and have the authority to carry out such duties to comply with the regulatory requirements. Such requirements include both routine maintenance and requirements in the event of damage or failure of the device as well as several reporting requirements.
- 8. Can I relocate my gauge (s) from one location to another?
Some GL devices have been approved for installation and relocation by the general licensee, however, this does not apply to all GL devices. You should contact the manufacturer to determine if your gauge (s) has been approved for relocation / installation by the general licensee.
Required Routine Maintenance Maintain labels Comply with the instructions and precautions provided on the labels Perform leak tests evety six months (unless in storage or otherwise indicated on the label) and maintain this record for three years.
Perform shutter tests every six months (unless in storage or otherwise indicated on the label) and maintain this record for three years.-
Requirements if the Device Becomes Damaged or Fails a Shutter or Leak Test Suspend operation of the device.
Have the device repaired or properly disposed of by the manufacturer.
Report to the NRC within 30 days a brief description of the event and remedial actions taken and a plan (if contamination is measured as greater than 0.005 microcuries (185 Bq)or likely to have resulted) for ensuring that the premises and environs are acceptable for unrestricted use.
K-3 Draft NUREG - 1556, Vol.16
r 3
- s APPENDIX K Reporting Requirements (Applicable to All General Licensees)
Type of Report Contents of Report Frequency Send to l
Transfer or disposa! Identification of device by Within 30 days of Director of NMSS, repon (Note: This report manufacturer's name and model transfer or U.S. NRC, is not needed ifobtaining number, serial number, name, address disposal. Washington, DC 20555.
a replacement device and license number of recipient, and from the same date of transfer.
distributor).
Transfer report for Manufacturer's name and model Within 30 days of Director of NMSS, change of ownership number, serial number, name and transfer.. U.S. NRC, (where device remains in address of the transferee, and name of Washington, DC 20555.
use at a particular the responsible individual of the location). transferee.
Report if device becomes Brief description of the event and Within 30 days of Director of NMSS, damaged or fails a shutter remedial actions taken and a plan (if occurrence. U.S. NRC, or leak test. contamination is measured or likely) Washington, DC 20555.
for ensuring that the premises and environs are acceptable for unrestricted use.
Report of change of New mailing address where device is Within 30 days Director of NMSS, mailing address of the used or stored. after moving the U.S. NRC, location of use. (Note: in device. Washington, DC 20555.
the cass of portable devices, this only applies to the mailing address of the desice's primary place of storage.)
Report ofincidents, lost, The following information: Telephone report Administrator of the or stolen devices. (A) Description of the radioactive within 30 days of appropriate NRC material occurrence; written Regional Office.
(B) Description of the circumstances report in 30 days under which the loss or theft of the telephone occurred report.
(C) Disposition of the radioactive material (D) Radiation exposure to individuals (E) Actions taken to recover the material (F) Actions taken to prevent recurrence.
Draft NUREG 1556, Vol.16 K-4
F , e APPENDIX K Additional Reporting Requirements for GL Devices Subject to Registration l
l Type of Report Contents of Report Frequency Send to l
Registration The following information and any Annual Addressee to be otherinformation specifically specified in registration requested by the NRC: request from NRC. .
1 (A) Name and mailing address (B) Information about each device:
the manufacturer, model number, serial number, the radioisotope and activity (C) Name and telephone number of the responsible individual
)
(D) Address where the device (s)are used and/or stored (E) Certification that the information concerning the device (s) has been verified through a physical inventory (F) Certification by the responsible individual that they are aware of the requirements of the general licensee Bankruptcy Notification of a voluntary or immediately Administrator of the involuntary petition for bankruptcy following the filing appropriate NRC under any chapter of Title 11 of e voluntary or Regional Office (Bankruptcy) of the U.S. Code involuntary petition for bankruptcy
- 9. Is there reciprocity for GL devices?
No, there is no reciprocity provision applicable to general licensees. The general license in 10 CFR 31.5 only applies within NRC jurisdiction. General licen' sees intending to move from one jurisdiction to another should contact the applicable regulatory authority, NRC, or the particular Agreement State prior to doing so in order to determine the applicable, current regulations in theirjurisdictions. Alljurisdictions do not have a comparable general license, and specific provisions of the general license may vary amongjurisdictions. Also, if a general licensee who has obtained a portable device in an Agreement State and wishes to use the device within NRC jurisdiction, it must do so under 10 CFR 31.5, as there is no reciprocity provision applicable to general licenses. In this case, the general licensee would be subject to the provisions of 10 CFR 31.5.
K-5 Draft NUREG - 1556, Vol.16
+ o APPENDIX K
- 10. How can I get rid of a GL device?
GL devices can only be transferred (for disposal or to obtain a replacement device) to: (1) a person holding a specific license pursuant to 10 CFR Parts 30 and 32 or equivalent Agreement State regulations,'such as the device manufacturer; or (2) a person holding a specific license that authorizes waste collection, such as a waste broker, unless specifically authorized by the NRC. However, in the specific case of change of ownership where a GL device remains in use at a particular location, the new owner will be the new general licensee.
Note: GL devices that are not being used can only be stored up to two years. After two years, the device must be properly transferred. During this time period of non-use, the shutter must be locked in the closed position.
- 11. Who can I go to for additional questions?
Call the device manufacturer who should be able to assist you. If the manufacturer is no longer in business, or you cannot contact the manufacturer, call the appropriate NRC regional office or the Agreement State for assistance. Listed below are phone numbers for the NRC Regional Offices.
- 12. What requirements apply?
Persons who possess devices listed in 10 CFR 31.5, and/or who possess tritium or promethitun-147 in luminous safety devices for use in aircraft under 10 CFR 31.7 are
. exempt from the requirements of Parts 19,20, and 21, with the exception of the provisions in 10 CFR 20.2201 and 20.2202. Persons who possess strontium-90 contained in ice detection devices under 10 CFR 31.10 also are exempt from the requirements of Parts 19, 20, and 21, with the exception of the provisions in 10 CFR 20.2001,10 CFR 20.2201, and 10 CFR 20.2202.
l Drafi NUREG - 1556, Vol.16 K-6
a .
APPENDIX K Locations of NRC Offices and Agreement States Region IV Region 111 gg WA MT ND %
WI h SD Mi MA 9 on l
- orc ] ID Y ,
wy IA RI 8 PA e NE IN OH IL NJ CT NV- M 1)T m .
w D.C.
DE MD AZ NM AR pj m a, . c AK VY FL C 4 Region 11 Region il PR 61 Forsyth Street, SW, Suite 23T85 Atlanta, GA 30303
- RegionalOffice Q Headquarters 404 562-4400, 1-800-577-8510 O 30 Agreernent States Region 111 (approx.15,800 specific licensees) Headquarters 801 Warrenville Road O 20 Non4greernent States Washington, D.C. 20555-0001 Lisle, IL 60532-4351 301-415-7000, 1-80 4 368-5642 630-829-9500, 1-800-522-3025 (approx. 6,000 specific licensees)
Note: Alaska and Hawaii are included in Region i Region IV Region IV, Puerto Rico and Virgin Islands 475 Allendale Road 611 Ryan Plaza Drive, Suite 400 in Region ll, The District of Columbia in King of Prussia, PA 19406-1415 Arlington, TX 76011-8064 Region 1 610-337-5000,1 800-432-1156 817-860-8100, 1-800-952-9677 BCC001b ppt 033199 Figure K.2 U.S.. Map.
K-7 Draft NUREG - 1556, Vol.16
Appendix L General License Registration Form FORM FOR CERTAIN DEVICES LISTED IN 10 CFR 31.5 L .
,r .
APPENDIX L '
General License Registration Form FORM FOR CERTAIN DEVICES LISTED IN 10 CFR 31.5 This Appendix reserved for Registration form which is under development.
l I
I L-1 Draft NUREG - 1556, Vol.16 1
i
I
' Appendix M Material License Form 374 Format
, ,o APPENDIX M Materials License - Form 374 Format The following pages show examples of a "G" license.
M-1 Draft NUREG - 1556, Vol.16
1 Appendix M e .
"C U.s. NUCLEAR REGULATORY Commission O t i MATERIALS LICENSE Purc int to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10 Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations hIr;tofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) desi n sted below; to dIliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shlll be deemed to contain the conditions specified in section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
Licensee in accordance with letter dated January 26,1998,' ,
- 1. Industrial Gauging Corporation, Inc 3. License number 37-XXXXX-02G is amended in its entirety toWad as follows:
[ 2.1234 Corporation Drive 4. Expiration date July 31, 2001 l
Anytown, Pennsylvania 60540 5.-Docket No. 030-XXXXX (y s y s ,a Reference No:
- 6. Byproduct, source, and/or special 7. Chemical and/or'physhi form 8. Maximum amount that licensee may nuclear material g;JA possess at any one time under this license g:A Qiv y s.s "
e#v A. As specified in Condition 11 A. As'specified in Condition 11 A. Not applicable Authorized use: 4 74 g.,
- ~
A. Pursuant to 10 CFR 32.51' the licensee is authorized to distribute the devices containing sealed sources specified in Condition 11 of this license to persons generally licensed pursuant to 10 CFR 31.5, or equivaleid ovisions of the regulations of any Agreement State.
CONDITIONS
- 10. The licensee may distribute material from Industrial Gauging Corporation,1234 Corporation Drive, Anytown, Pennsylvania, l
l
.f l Draft NUREG 1556, Vol.16 M-2
r e & Appendix M l
NRC FORM 374A U.s. NUCLEAR REcULATORY COMMISSION PAGE 2 of 4 PAGES l License Number 37-XXXXX-02G MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-XXXXX Amendment No.10 1
- 11. Each device distributed pursuant to the conditions of this license shall be m accordance with the following table:
Maximum Activity Per ,
A Source l Device Model Number _ isotope Source Model Number (Millicuries) .
LB 300 IP D or L Cesium 137 P-2623-100%jf' h //g 30 CDC.P4, CDC'.7007 C pC.93,,Cs7.P02~-A or fCs7.,PO434y" l y ;; 97 LB 300 L Cobalt 60 5 kPf2608-100/101 500 LB 300 L Cesium 137 2 *SK
[%
Xp 1208NZ-287 500 LB 300 LP (h$h A h Cobalt 60%7 p _ P-2602-100 100 LB 300 LP Ceisiumj37k P-2623-100 500 LB 300 LP Cesiiimn37Q 2645.100-000 or
'( $W CDC.93 or CDC.700 1000 I
LB 330 i [bhait bO' P 2651-201/202 10 T -
P 2608-100/101 l LB 330 CChsium 137 2653.100-000 40 LB 330 Americium 241 2663.000-000 200 LB 375 Curium 244 2657.000-000 10 LB 375 Cesium 137 P-2623-100 100 LB 375 Americium 241:Be 2611.100 300 i
LB 379 Americium 241 P 2642-100 - 100 LB 7440 D or F Cobalt 60 P-2602-100 10 LB 7440 D or F Cesium 137 P-2623-100 500 i LB 7440 D or F ,
Cesium 137 CDC.700 300 l LB 7440 D or F Cesium 137 Cs7.PO2/-A 500 I LB 7442 D or F Cobalt 60 P-2602-100 100 LB 7442 D or F Cesium 137 2645.100-000 100 LB 7442 D or F Cesium 137 CDC.93 3000 LB 7442 D cr F Cesium 137 Cs7.PO4/-A 3000 l
i M-3 Draft NUREG - 153, Vol.16 l
Appendix M __ ,
s .
NRC FORM 374A u.s. NUCLEAR REGULATORY CoMMISSloN PAGE 3 of 4 PAGEs Lic'sase Number 37-XXXXX-02G Docket or Referene s Number MATERIALS LICENSE SUPPLEMENTARY SHEET 030-XXXXX Amendment No.10 Maximum Activity Per Source pevice Model Number Isotope Source Model Number (Millicuries)
_.s, LB 7444 D or F Cobalt 60 P-2602-100h 6 500 LB 7445 D or F Cobalt 60 P-2602-100 10 LB 7445 D or F Cesium 137 P-2623-100'2. 'd ,qb g g 500 LB 7445 D or F Cesium 137 CDC.700 9$9 300 LB 7445 D or F Cesium 137 Cs7.PO2/-A c:[# 500 LB 7446 D or F Cobalt 60 f2'% t18 u P-2602'-1007 100 LB 7446 D or F Cesium 137 a. g$2645.100-000 3000 LB 7446 D or F Cesium 137 ' k ';CDC.93 ~
3000 LB 7446 D or F Cesium 137 3000 din' %gM)Cs7.PO4/-A h +
LB 74f4 Series N.;.y i (conveyor belt) Cesium,137 %p 30
%gp 6' LB-AS P 2627-100 or o
N,E, .c%
Ameridum 241 n.m ..
P 2642-100 300 ht M1;L Y LB-BW ' K[ypton 85 KAC.D3 200 LB-BW QStrontium 90 SIF.P1 10 LB-BW Curium 244 CLCL 200 LB BW Americium 241 AMC.D2 10 LB-BW Americium 241 AMC.D3 30 LB-BW Americium 241 AMC.16 100 LB-BW Americium 241 AMC 17 300 NW-201 Series Cesium 137 BSI39002 0.01 NW-301 Series Cesium 137 BSI 39002 0.01 NW-401 Series Ce:Am 137 BSI39002 0.01
- 12. This licensnioes not authorize possession or use of licensed material.
Draft NUREG - 1556, Vol.16 M-4
, es Appendix M l \
NRC FORM 374A u.s. NUCLEAR REcuLAToRY C,oMMISsloN PAGE 4 of 4 PAGEs License Number 37-XXXXX-02G MATERIALS LICENSE o cket or Reference Number SUPPLEMENTARY SHEET 030-XXXXX l
l Amendment No.10
- 13. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations. &
ll p A. Application dated March 15,1985
( .if g' B. Letter dated May 19,1986 C. Letter dated March 20,1987 4x
% Ni p/
D. Letter dated June 27,1988 s A E. Letter dated March 15,1989 F. Letter dated March 21,1989 8,qD EV 4' G. Letter dated November 7,1989 a%d
'H. Letter dated April 6,1990
- l. Letter dated October 10,1990 QQ MV 4 J. Letter dated January 24,1991 qjg $@! gd,p K. Letter dated May 28,1991 M L. Letter dated June 20,1992 y gg, g4;4;)
M. Letter N. Letter dated dated August 18,1992 July 19,1994, s e .f g [fg, p O. Letter dated May 23,1997 a wg P. Letter dated July 2,199861.@ P '
O. Letter dated August 21 1998)
R. Letter dated August 25,1998 f 4
For the U.S. Nuclear Regulatory Commission D:te: finsert license issue datel By: Oriainal sianed by finsert reviewer's namel
[ insert reviewer's name] 1
[ insert reviewer's NRC address]
M5 Draft NUREG - 1556, Vol.16 l
l'
Appendix M
+ .
U.s. NUCLEAR REGULATORY Commission Amend ent No 01 MATERIALS LICENSE Pursuant to the Atomic Fnergy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36, 39,40, and 70, and in reliance on statements and representations hIretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to diliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shill be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
Licensee in accordance with dated A
November 14g99g
- 1. Any Pharmaceutical Manufacturing Company X Medical Products Division 3.entirety Ucenseto read numtie@[as)XXXX-02G ollows:
2.1234 Main Street 4. Expiration date Janua'y r 31,2000 Boston, Massachusetts 60540 S M etNo.0 4 < n y.v .
, QeferenQ , .
- 6. Byproduct, source, and/or special 7. Chemical arid /or [ form 8. Maximum amount that licensee may nuclear material 7% t possess at any one time under this license A. Hydrogen 3 A. Prepah "in vitro kits A. Not applicable A
B. lodine 125 B.;
~
in vitro kits B. Not applicable b"
Authorized use: Q A.andB. Pursuant to 10 b the licensee is authorized to distribute in vitro kits containing prepackaged unitsfopersons generally licensed pursuant to 10 CFR 31.11, or equivalent provisions of the regulafions of the regulations of any Agreement State.
CONDITIONS
- 10. The licensee may distribute in vitro kits from 1234 Main Street, Boston, Massachusetts.
- 11. This license does not authorize possession or use of licensed material.
Draft NUREG - 1556, Vol.16 M-6
n e o Appendix M NRC FORM 374A U.s. NUCLEAR REGULATORY Commission PAGE 2 of 2 PAGES License Number 37-XXXXX-02G MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-XXXXX Amendment No. 01
- 12. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.
.y A ,
A. Application dated November 14,1998 ';
. - , /F ah '
r, ;
n A,-
v% f% f.
g h],
'c (N..f .# 4.
,cm, y,.
f [ *k$j b ; [6 7 f
A ,
e.
[, 'Q.aw:c %q
/; h $ N Y % %>
- NQMwsQ q+.h,9 j% Ma
G A %If
.3 hw; )f &
m ke
_ q :, " >:j
,y, .
.- e, ru.f{!
w u. I' For the U.S. Nuclear Regulatory Commission D te: Iinsert license issue datel By: Oriainal sioned by finsert reviewer's namel
[ insert reviewer's name]
[ insert reviewer's NRC address)
- 2--
M-7 Draft NUREG - 1556, Vol.16
m Q (h i
l l
Appendix N Deemed Timely Letter
OA e l.
APPENDIX N
_ Deemed Timely Latter
[Date] ,
License No. XX-XXXXX-XXG Docket No. 030-XXXXX Mail Control No. XXXXXX
- [ Licensee's Name] ,
_-).
, : ATTN:-[
[ Street /P.O. Box]
(City, State Zip]
SUBJECT:
Dear [ _']:
This is to acknowledge receipt of your application for renewal of the materials license identified above.' Your application is deemed timely filed and, accordingly, the license will not expire until final action has been taken by this office.
Any correspondence regarding the renewal application should reference your license number and the mail control number specified above.
Sincerely, i
[ Licensing Assistant]
l 1
I i
l l
N-1 Draft NUREG - 1556, Vol.16 i
L
l c l Appendix O Form NRC-483 " Registration Certificate ;
-In Vitro Testing with Byproduct Material Under General License"
n APPENDIX O Form NRC 483 " Registration Certificate -In Vitro Testing with Byproduct Material Under General License" C roRh. . p . - mTo,t7 & -- - .u- - o,et-
~
llllll",:lllll 'T."llll"4 llllL? ll:=l"ll'. ~
REGISTRATION CERTIFK: ATE - he v4m TESTING *:llllll", ",llll"",,,"lll"." *"0 = ",,,",,",,,",,lll,lll'"O
., l WITH BYPRODUCT MATERIAL UNDER C ** """* e m.,u *c"*le2. "* 'll"O GENERAL UCENSE mllll"'* """ee'"a'"m'sT .*."." ". . , .,lll'l
"""m.,*.l""l"ab"s"."".".,*,o"""""'*""'"""""'
Senten 31.11 af to CP1t 31 mahamhss a gensruf Buenme aumermig phyeomune. ekueel kW henseeds, and _ . _ m the preshoe of vueurbiery moismo to pomenes estum snuA quarmas of hypreene puhstal for h tes ehemel er tubaruhry tuute fut tuveheg sie keurnal er gutemmi W em typroduma nummed w me smessen sensem to Pasumi homes er eremma Pomessman of appresust means unser 10 CFR 31.11 as not mahermed wes ou phyumem, senhal meeremry. hampaul, er ausstenen m the puestos af vetumery maestie. has And NRC Fann W and renamed frorn the Comnumman a umgested supy of NRC Fann e umt a aguseman neuter.
- 1. NAAAE AfD ADDMSS op ApFRJCANT (See mesumenn 3& tammy & ApFUCATIoti (Check onesum sney1 1 husby 1pply hr a suglutruman nunear pusiert to 10 CFR 31'. Sachen 31.11.1mr une of typseeset metelmis tur A h8pusw.e edy Anerund phyusse aupasted to emperne arqps m me asemane of moeums.
- s. The amend amuremry naastecossaamme pummemescumu C. Theammenunselumphal o vammounen an so unmeme er veennnev meanse 3, ggTgug;yggggg 4. MTMlle A' "'"*'"""*8"'"'" REGISTRATION NutdBER:
timeses. Assemum and Cansamous use salmer asush(T4 ps)
Deann af tuhmansl and essend Nummer Sefuty /p**"%eIq,'
omne er eeumamar sammui anney and asseguards !
U.S. Muuteur Augenmy Comunnamn 3 womenemn,DC saussanot *
(At NRC. a reghouten ameer uG be sangrad and e votested espy of AIRC Fem eudshesutumed.)
s.' m me tem ammve, pas er type su none, aseems (mensenh Zr Caen and tdeshow nummer of en rugmanne em eneses 8F 8" "' 8*'8'8 am, neve se assos esent-amneera se meuremry. hampas, er summeuuun m em pnusse of seemeury aemped my sstc.'** s'de is e enango oredhanssen tem e psomuusfy maasse sur amuss er sur uhah the msnmunen sann as est
888"udgamur anonse. siehado your ophoushn smeerJ
- s. r passe es uma e egense een aseems esame amme, sem esapane assens:
l
- e. outTipsCATices Ihousy emney put - l A. . As tiemnuman > ses reganomen estasses a tus and sumphen.
- s. The segmeent has appngstmo memhm numm.tg mutumards to esty eut the team for uNeh hypment meshi e8 he used wuder om gunsrei numme of to Crm 31.11. The immes me ne personned ordy by pumannel eengsamt in se uma af em 1___ _ and m en hones of ou appreemt memesa C. I undermaand tot Canummmhn seeddles fases out muy efuge ti the Difumukan tamashed try a spuhunt en ens legatchen eartRoste he separted to sie Duester of Mustuur testenal Salay and Safspands eGim 30 days tem en eAus#se des el ash eenga.
D 1 han sued mal undersaand ein punissons of Sseen 31.11 of Np" reguhuens 10 CFR 31 (repetnted en the reveres side of ses feroQ. and I unseruaand the the reglutand is ruoted to esmusy em emme pseutdans en to es tyynmaast autend uNeh he reennes, engeons . imes, w senuame woor en omnme seense ser usuch een mesmesman Counens a med im en u.s. Nunemer Resukserf Commmmen.
rv4NTED OR TTPED NARGE AND Tm.E OF APPUCANT 51GNATURE DF APPUCANT DATE WARNING FALSE STATHENTS N THIS CERTFICATE MAY BE SUBJECT TO CML ANDOR CRMNAL PENALTES. NRC REGULATIONS REQUIRE THAT es mahamar mes TO THE NRC BE COIWPLETE AND ACCURATE IN ALL MATERIAL RESPECTS. 18 U.S.C. SECTION 1001 MAMES TT A CRMNAL OFFENSE TO MAKE A WILLFULLY FALSE STATBENT OR REPRESENTATION TO ANY DEPARThENT OR AGENCY OF THE UNTTED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
.sec ean= = pem meessTnANrs coer i O-1 Draft NUREG - 1556, Vol.16
Appendix P Form XXX-Transfers of Industrial Devices Report ,
1 i
i
}
p:= ,g,4 a.
4 APPENDIX P Form XXX-Transfers of industrial Devices Report
' An example of Form XXX, Transfers ofIndustrial Devices Report appears on the following page.
1 1
P-1 Draft NUREG - 1556, Vol.16 l
7 l'
Form XXX - Transfers of industrial Devices Report P?O3 of. _
l Nams of Vendor: Reporting Period:
l License Number: From: To:
l' For etch " person" to whom a device (s) has been transferred during the reporting period, supply the following:
l Intermediate Person (if any) l N me:
- cnd Street:
City, State, and Zip Code:
N me of Responsible Individual:
l Telephone number:
l General Licensee User Information l
Nrme:
Department:
- and Street:
City, State, and Zip Code:
NIme of Responsible Individual: Telephor:e number:
l Information on Device (s) Transferred: l Dits of Transfer: /# Type of Device: Model Number: Serial number: llsotope: Activity and Units-replacement l l
In the case of replacements, provide following for device (s) rec;Ned:
Intermediate Person (if any)
Name:
- (nd Street:
City, State, and Zip Code:
Name of Responsible Individual:
l Telephone number:
l General Licensee User information l
Nime:
Department:
0 tnd Stieet:
City, State, and Zip Code:
NIme of Responsible Individual:
l Telephone number:
l Information on Device (s) Transferred: l Data of Transfer: /8 Typc of Device: IWodel Number Serial number: l Isotope: Activity and Unsts:
re,lacement
[
In the case of replacements, provide following for device (s) receNed:
Draft NUREG - 1556, Vol.16 P-2
.. , 1 Appendix C Sample (SSD) Registration Certificates for Generally Licensed Products l
l
F APPENDIX C Sample (SSD) Registration Certificates for Generally Licensed 1 Products Sample (SSD) Registration Certificates for Generally Licensed Products appear on the following pages.
i C1 Draft NUREG - 1556, Vol.16
APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 1 OF 11 DEVICE TYPE: Transmist/.on Gauge MODEL: TG-1 (formerly registered as the Models 0-7, U-7, and U-7D)
MANUFACTURER /DISTRIBUTCP: [ Manufacturer's name and address goes here]
SEALED SOURCE MODEL DESIGNATION: ABB Models: S-11 S-16 S-18 S-20 Amersham Model: CLC.DI ISOTOPE MAXIMUM ACTIVITY MODELS Promethium-147 1000 millicuries (37 GBq) S-20 Krypton-85 1000 millicuries (37 GBq) S-11 Strontium-90 70 millicuries (2.6 GBq) S-18 Curium-244 1000 millicuries (37 GBq) CLC.DI Americium-241 5000 millicuries (185 GBq) S-16 LEAK TEST FREQUENCY: 6 Months Not required for Krypton-85 PRINCIPAL USE: (D) Gamma Gauge (containing Cm-244 or I Am-241) l (E) Beta Gauge (containing Pm-147, Kr-85 or ]
CUSTOM DEVICE: _ YES X NO 1
l Draft NUREG - 1556, Vol.16 C-2 1
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, APPENDIX C -
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 2 OF 11 DEVICE TYPE: Transmission Gauge DESCRIPTION:
The Manufacturers Model TG-1 device is designed for gauging physical characteristics of processed materials such as the thickness, density, weight per unit area or length, or composition of the measured material. The device is always mounted in a fixed geometry with a detector housing. The detector housing is mounted in front of the beam port of the device. The material to be measured is either passed between the device and detector or the device and detector are moved simultaneously, maintaining their geometrical relationship, over the material to be measured. The air gap between source housing and detector ranges from 0.5 cm (0.20 inch) to 10 cm (3.93 inch) for beta emitting sources and up to 50 cm (19.69 inch) for gamma emitting sources.
The device is installed at fixed locations by the manufacturer or another specific licensee of NRC or an Agreement State which is licensed to do so. The device may be installed into existing manufacturing equipment or onto a frame or scanner which is incorporated into the process. The device may be mounted in laboratory or similar locations.
The dimensions of the device range from 190 to 243 mm (7.48 to 9.57 inches) high by 419 mm (16.G0 inches)long by 203 mm (7.99 inches) wide. The device consist of an outer shell, the {
sealed source, source holder, shutter mechanism, source holder adapter, and various electronic components. A drawing of the device is shown in attachment 1.
The outer shell consist of four pieces, the source base plate, source head, and two side covers.
The source head, three sides of the box shape, is either cast from aluminum or fabricated from steel. It has a minimum wall thickness of 6.4 mm (0.25 inch). The source base plate is fabricated from steel,19.1 mm (0.75 inch) thick, and mechanically fastened to the enclosure with heavy duty latches. The side covers are made of aluminum or steel and are 6.4 mm (0.25 inch) thick. The side covers are bolted in place and locked to prevent removal. When needed, insulating material is inserted between dissimilar material interfaces.
1 C-3 Draft NUREG 1556, Vol.16
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APPENDIX C . l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: ' NR-109-D-122-B DATE: June 27,1994 PAGE 3 OF 11 DEVICE TYPE: Transmission Gauge DESCRIPTION (Cont.):
I The source holder adapter is' fabricated from steel and is bolted to the source base plate. It has !
a minimum thickness of 15.8 mm (0.62 inch). j i
The shutter mechanism is operated by an air or electric actuator. The actuator is equipped with l a fail-safe spring mechanism which will automatically retum the sintered tungsten or stainless steel shutter to the closed position if there is a power failure. ;
The source holder contains the sealed source and is fabricated from steel and/or sintered tungsten and lead shielding. The combination of materials and dimensions of the source holder depends on the isotope. The source contained in the device may be one of the sources listed l on the first page of this document with the maximum activity listed.
i The device is designed to withstand the environmental conditions listed in this document. If-more extreme conditions are expected or realized, the manufacturer may substitute different materials for the source base plate, scurce nead, and side covers and/or may plate, coat or treat these components to achieve higher performance. Upon doing so, the manufacturer is required to submit details of the environmental conditions and design specifications of the device to the i ' Source Containment and Devices Branch, NRC.
The device is operated as part of a larger meas'urement and control system which is computer L controlled. The computer control system may be located in a remote location. The system i
software and logic determines if the conditions are appropriate (material to measured is present, line is moving, etc.) for the shutter to open. Th? operator cannot override the system logic and open the device shutter mechanism. However, the operator at the computer can close the shutter by executing a command such as "Off sheet" which will automatically close the shutter.
The device may also be equipped with a mechanism which allows the shutter to be closed by executing a lock-out control at the operator's station or at the scanner.
The shutter position is indicated by lights in the immediate vicinity of the device. The lights are red (shutter open) and green (shutter closed). An illustration the indicator lights for O-frame installations is shown in attachment 2.
~ Draft NUREG - 1556, Vol.16 C-4 L
i o e APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE 4 (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 4 OF 11 DEVICE TYPE:- Transmission Gauge
' DESCRIPTION (Cont.k Large lantern lights are mounted to U- or C-frame applications. The lights are mounted so they are readily visible to anyone working in the area near the device. Additional indicator lights may be located throughout associated areas. This could include lights or video displays at the operators monitoring and control stations.
The ABB source models listed on the first page of this document (and in attachment 4) are approved for use only in the Model TG-1. The sources mig'ht not registered on separate certificates. The sources are manufactured to ABB specifications by Amersham Corporation or Du Pont Merck Pharmaceuticals.
The Model TG-1 replaces the ABB Models 0-7, U-7, and U-7D. The primary change is that the Model TG-1 is the source housing which was used in the Models 0-7, U-7, and U-7D and this change allows the device to be mounted to various types-of frames or existing process machinery.
LABELING:
The device is labeled in accordance with Section 20.203,10 CFR Part 20. When distributed to persons generally licensed, the device is additionally labeled in accordance with the requirements of Section 32.51,10 CFR Part 32. Copies of the labels are shown in attachment 3.
Label A is self-adhesive and will be attached to the source holder. The label will include isotope, activity, and d ' n assay of the source contained in the source holder. The label has a yellow background witn black lettering and magenta trefoil symbols.
Label B is attached to the end of the device and to the outer shroud, carriage, frame, or mounting assembly containing the device so that it is clearly visible after the device is installed.
Label B is either self-adhesive with the added information (isotope, activity, date of assay, serial number, model number, test interval, and distence specification) entered by typing and covered by a clear laminate or is fabricated from anodized aluminum, attached with screws, and the information die stamped.
C-5 Draft NUREG - 1$56, Vol.16
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' APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 5 OF 11 DEVICE TYPE: Transmission Gauge LABELING (Cont.h The manufacturer will choose a label sufficient to withstand the environment in which the device is installed. The label has a yellow background with black lettering and a magenta trefoil symbol. '
Additionally, label C will be attached to the end of the devices distributed to general licensees.
The label will be attached to the device and to the outer shroud, carriage, frame, or mounting assembly containing the device so that it is clearly visible after the device is installed. The Label is either self-adhesive and covered by a clear laminate or is fabricated from anodized aluminum, attached with screws. ABB will choose a label sufficient to withstand the environment in which the device is installed. The label has a white background with black lettering.
The manufacturers name is displayed on other labels and emblems attached to the supporting structures of the device.
The manufacturers source models are engraved or stamped with the isotope, activity, serial number, and date of manufacture.
DIAGRAM:
See attachments 1-4.
CONDITIONS OF NORMAL USE:
The device is intended for use in industrial gauging applications. Typical environments are those associated with measurement and control applications such as paper machines, metals rolling mills, plastics extrusions lines, fiberglass mat lines, or tire fabric calendars. Operating L temperatures may vary from O'C to 200*C (32'F to 392*F). The temperatures will typically not
[ -exceed 1250C (257'F). The device will withstand humidity up to 100% RH. Vibration, shock, and corrosion will be typical of those associated with applications listed above.
l-In operation in non-bonign environments, the source housing is typically temperature controlle'd.
It may be purged.
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Draft NUREG - 1556, Vol.16 C-6
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APPENDIX C l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 6 OF 11 DEVICE TYPE: Transmission Gauge CONDITIONS OF NORMAL USE (Cont.h This controlled intemal environment is designed to prevent condensation and corrosive conditions that might adversely effect shutter operation.
If the source housing is to be subjected to more extreme environments which would require different materials of constructions, or coatings or treatments of the materials, the manufacturer shall make the substitution and upon doing so shall submit the environmental conditions and design specifications to the Source Containment and Devic'es Branch, NRC.
PROTOTYPE TESTING:
According to the manufacturer, the expected useful life of the shutter design is 200,000 cycles.
This represents the typical number of shutter operations a device may encounter during 10 years of use. 1 A prototype of a shutter mechanism (source, source holder and complete shutter mechanism) similar in design to the Model TG-1 shutter mechanism was subjected to the Underwriters Laboratories four hour fire test. The test consisted of the device being subjected to a temperature of 2000* F (1093* C) for four hours followed by being dropped six feet while incandescent. The shutter mechanism was then immediately quenched in water at 68'F (20*C) and then dropped fifteen feet on each of its three major axes. After the test, the source remained in the device and leak tests indicated no leakage of byproduct material.
As stated, the Model TG-1 has been manufactured and distributed as part of the Models 0-7, U-7, and U-7D. The device has demonstrated the capability to withstand the typical shock, vibration, and corrosion expected in typical operating environments.
The Models NER-584 and CLC.DI have been tested and meet the ANSI N542-1977 classifications of 77C33232 and 77C64344 respectively. A138 has indicated that their source models meet the ANSI N542-1977 classifications listed in the table in attachment 4.
C-7 Draft NUREG - 1556, Vol.16
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APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 7 OF 11 DEVICE TYPE: Transmission Gauge EXTERNAL RADIATION LEVELS:
The following is the maximum external radiation levels from the device when mounted with a detector unit. These levels were taken from isodistance radiation pattems submitted by the manufacturer. The manufacturer states the patterns were prepared using the procedures specified in ANSI N538-1979 'and represent the worst case situations as determined from data of actual measurements of all of the geometric combinations envisioned.
Containing a 1000 mCl, promethium-147 source and having a 13 mm (0.51 inch) air gap ,
between the source housing and detector:
Max. Radiation Level Distance Shutter open Shutter closed
[c.IId 60.1 mR/hr uSv/hr mR/hr uSv/hr 5 1.97 6.8 68 Background 30 11.81 Background Background 100 39.37 Background Background i
I I
l Draft NUREG - 1556, Vol.16 C-8
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APPFNDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 8 OF 11 UEVICE TYPE: Transmission Gauge EXTERNAL RADIATION LEVELS (ContJ As stated, the above levels represent the worst case mounting configurations. However, once j installed the extemal radiation levels may be ' lower because of extemal shielding. In addition,
)
E because these housings are usually mounted within a frame or existing machinery, the workers will usually not be able to get within 30 cm of the device.
When installed at a general licensees facilities, the radiation levels will be controlled with extemal shielding, barriers, and location such that dose rates at continuously occupied work stations will not exceed 0.25 mR/hr (2.5 uSv/hr). In addition, maximum radiation levels on the surface of the application will not exceed 50 mR/hr (500 Sv/hr) when the shutter is in the closed position.
QUALITY ASEURANCE AND CONTROL:
The Manufacturer maintains a quality assurance and control program which has been deemed acceptable for heensing purposes by NRC. A copy of the program is on file with the Source Containment and Devices Branch.
1 C-9 Draft NUREG - 1556 Vol.16 i
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APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 9 OF 11 DEVICE TYPE: Transmission Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The device may be distributed to specific or gaeral licensees of NRC or an Agreement State.
I Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
Source housings intended for use under a general license shall be initially tested for extemal radiation levels, required labels, and leakage / contamination of radioactive material by persons specifically licensed by NRC or an Agreement State.
The device, except when it contains Kr-85, shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
When installed at a general licensees facikties, the radiation levels shall be controlled such that dose rate levels at continuously occupied work stations will not exceed 0.25 mR/hr (2.5 Sv/hr).
Maximum radiation levels on the surface of the application shall not exceed 50 mR/hr (500 uSv/hr) when the shutter is in the closed position.
When the source housing is to be subjected to extreme environments which require different materials of constructions, or coatings or treatments of the materials, the manufacturer shall make the substitution and upon doing so shall submit the environmental conditions and design specifications to the Source Containment and Devices Branch, NRC.
When the device contains a beta emitting source, the air gap between the source housing and the detector unit shall not exceed 10 cm (3.93 inches).
When the device contains a gamma emitting source, the air gap between the source housing and the detector unit shall not exceed 50 cm, (19.69 inches).
Servicing of the source housing, including installation and removal, and mechanisms essential to its inherent safety features (e.g. extemal shielding, automatic shutter closing mechanisms) shall be performed by persons specifically licensed by NRC or an Agreement State.
Draft NUREG - 1556, Vol.16 C-10 t .. .
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APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFET/ EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 PAGE 10 OF 11 DEVICE TYPE: Transmission Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont.):
. The manufacturers models S-11, S-16, S-18, and S-20 are approved for use in the Model TG-1 as part of this registration.
l 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 manufacturer /distribuitor has submitted sufficient information to provide reasonable assurance that:'
The device can be safely operated by persons not having training in radiological protection.
Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the source housing, and it is unlikely that any person will receive in any period of one year a dose in excess of 10% of the limits specified in Section 20.1201(a),10 CFR Part 20. j Under accident conditions associated with handling, storage, and use of the source housing, it is l unlikely that any person would receive an extemal radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the following chart:
PART OF BODY DOSE Whole body; head and trunk; active blood-forming organs; gonads; 15 rem (0.15 Sv) or lens of eye Hands and forearms; feet and ankles; localized areas of skin 200 rem (2.0 Sv) ,
averaged over areas no larger than 1 square centimeter i Other organs 50 rem (0.50 Sv) l l
l C-11 Draft NUREG - 1556, Vol.16 l m.
m APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATF.: June 27,1994 PAGE 11 OF 11 DEVICE TYPE: Transmission Gauge SAFETY ANALYSIS
SUMMARY
SECTION (Coni.);
Basad on review of the Model TG-1 device, the information and test data cited below, and the years of usage as part of the Models 0-7, U-7, and U-71), we conclude that this device is acceptable for licensing purposes.
Furthermore, we conclude that this device would be expected to maintain it's containment integrity for normal conditions of use and likely accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model TG-1 are hereby incorporated by reference and are made a part of this registry document.
Manufacturers application dated July 23,1991.
Manufacturers letters dated April 21,1993 (two letters), and August 13,1993, with enclosures thereto.
Manufacturers dated July 2 1993, July 6,1993, and October 18,1993.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: June 27,1994 Reviewer John Lubinski Date: June 27,1994 Concurrence:
Steven L. Baggett Draft NUREG - 1556, Vol.16 C-12 i >
o a APPENDIX C REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
No.: NR-109-D-122-B DATE: June 27,1994 ATTACHMENT 3 LABELS
[ example of the manufacturers propr> sed labeling of the device would go here]
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C-13 Draft NUREG - 1556, Vol.16 I
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l Appendix D 10 CFR 2.790: Withholding Letter l
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APPENDIX D 10 CFR 2.790: Withholding Letter i
[ Applicant Name]
[ ATTN:- Contact Name] ,
[ City, State Zip Code] j
Dear [ :
]
1
SUBJECT:
REQUEST FOR WITHHOLDING INFORMATION CONTAINED IN I LICENSE APPLICATION By NRC 313, " Application for Material License," or letter from (Licensee's Name) dated
. and affidavit dated . you submitted proprietary material consisting of client ,
information and requested it be withheld from public disclosure pursuant to 10 CFR 2.790.
You stated that the submitted information should be considered exempt from public disclosure i for the following reasons: l l
1.
i 2.
l We have reviewed your application and the material in accordance with the requirements of !
$2.790 and, on the basis of your statements, have determined that the submitted information may/may not be withheld.
Therefore, we have determined that the information contained in Items ofNRC Form I 313 or letter from (Licensee's name) dated . marked as proprietary, will be withheld from public disclosure pursuant to f2.790(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended. Your request for withholding will be maintained by this Office indefinitely or for as long as you continue to hold NRC License No. - -
G.
Withholding from public inspection will not affect the right, if any, of persons properly and directly concemed authorized to inspect the documents. If the need arises, we may send copies of this infonnation to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.
l If the basis for withholding this information from public inspection should change in the future such that the information could be made available for public inspection, you should promptly notify the NRC. You should understand that the NRC may have cause to review this j D-1 Draft NUREG - 1556, Vol.16 l-i
APPENDIX D determination in the future, for example, if the scope of a Freedom ofInformation Act request includes your infonnation. In all review situations, if the NRC makes a determination adverse to the abeve, you will be notified in advance of any public disclosure.
Sincerely,
[ Reviewing Official]
Draft NUREG - 1556, Vol.16 D-2
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APPENDIX D l
In order ' , request that the NRC withhold information contained in an application from public
, disclosure, the applicant must submit the information and application, including an affidavit, in accordance with 10 CFR 2.790. The applicant should submit all of the following:
[] A proprietary copy of the information. Brackets 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 portions intact. This copy should not be marked as proprietary.
[-] An affidavit that: i
[] Is notarized.
- [ -] . Clearly identifies (such as by name or title and date) the document to be withheld.
1
[] Clearly identifies the position of the person executing the affidavit. This person must be an officer or upper-level management official who has been delegated the function of reviewing the information sought to be witheid and authorized to apply for withholding on behalfof the company.
l
[] States that the cornpany submitting the information is the owner of the information l
or is required, by agreement with the owner of the information, to treat the )
information as proprietary.
[] Provides a rational basis for holding the information in confidence. i
[] Fully addresses the following issues- I I
[] Is the information submitted to, and received by, the NRC in confidence?
Provide details.
~ [] To the best of applicant's knowledge, is the information currently available in public sources?
[] Does the applicant customarily treat this information, or this type ofinformation, as confidential? Explain why.
[] Would public disclosure of the information be likely to cause substantial harm 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 information, and the ease or difficulty of others to acquire the information.
1 D-3 Draft NUREG - 1556, Vol.16
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1 Appendix E I
Information Needed for Transfer of Control Application (Excerpted from Information Notice 89-25)
D, .
1
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APPENDIX E l
l Information Needed for Transfer of Control Application (Excerpted I
from information Notice 89-25)
I Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license; some licensees refer to this as " transferring the license."
Provide the following information, excerpted from IN 89-25, Rev.1, " Unauthorized Transfer of Ownership or Control of Licensed Activities," concerning changes of control by the applicant (transferor and/or transferee, as appropriate). If any items are not applicable, so state.
- 1. The new name of the licensed organization. If there is no change, the licensee should so state. 1
- 2. The new licensee contact and telephone number (s) to facilitate communications. I
- 3. Any changes in personnel having control over licensed activities (e.g., officers of a
]
corporation) and any changes in personnel named in the license such as radiation safety officer, authorized users, or any other persons identified in previous license applications as responsible for radiation safety or use oflicensed material. The licensee should include information concerning the qualifications, training, and responsibilities of new individuals.
- 4. An indication of whether the transferor will remain in nonlicensed business without the license.
- 5. A complete, clear description of the transaction, including any transfer of stocks or assets, mergers, etc., so that legal counsel is able, when necessary, to differentiate between name changes and transferring control.
- 6. A complete description of any planned changes in organization, location, facility, equipment, or procedures (i.e., changes in operating or emergency procedures). j
- 7. A detailed description of any changes in the use, possession, location, or storage of the licensed materials.
- 8. Any changes in organization, location, facilities, equipment, procedures, or personnel that j would require a license amendment even without transferring control. l l
- 9. An indication of whether all surveillance items and records (e.g., calibrations, leak tests, surveys, inventories, and accountability requirements) will be current at the time of transfer. Provide a description of the status of all surveillance requirements and records.
- 10. Confirmation that all records concerning the safe and effective decommissioning of the facility, pursuant to 10 CFR 30.35(g),10 CFR 40.36(f),10 CFR 70.25(g), and E Draft NUREG - 1556, Vol.16
APPENDIX E 10 CFR 72.30(d); public dose; and waste disposal by release to sewers, incineration, radioactive material spills, and onsite burials, have been transferred to the new licensee, if licensed activities will continue at the same location, or to the NRC for license terminations.
- 11. A description of the status of the facility. Specifically, the presence or absence of contamination should be documented. If contamination is present, will decontamination occur before transfer? If not, does the successor company agree to assume full liability for the decontamination of the facility or site?
- 12. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35,40.36, and 70.25. Include information about how the transferee and transferor propose to divide the transferor's assets, and responsibility for any cleanup needed at the time of transfer.
- 13. Confirmation that the transferee agrees to abide by all commitments and representations previously made to NRC by the transferor. These include, but are not limited to:
maintaining decommissioning records required by 10 CFR 30.35(g); implementing decontamination activities and decommissioning of the site; and completing corrective actions for open inspection items and enforcement actions.
With regard to contamination of facilities and equipment, the transferee should confirm, in writing, that it accepts full liability for the site, and should provide evidence of adequate resources to fund decommissioning; or the transferor should provide a commitment to decontaminate the facility before transferring control.
With regard to open inspection items, etc., the transferee should confirm, in writing, that it accepts full responsibility for open inspection items and/or any resulting enforcement actions; or the transferee proposes alternative measures for meeting the requirements; or the transferor provides a commitment to close out all such actions with NRC before license transfer.
- 14. Documentation that the transferor and transferee agree to transferring control of the licensed material and activity, and the conditions of transfer; and the transferee is made aware of all open inspection items and its responsibility for possible resulting enforcement actions.
- 15. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If not, the transferee must provide a description ofits program to ensure compliance with the licose and regulations.
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l Draft NUREG - 1556, Vol.16 E2
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Appendix F l Review Checklist for General Distribution License Application (32.51)
, o APPENDIX F Review Checklist for General Distribution License Application (32.51)
ITEM 1: ACTION TYPE ACTION TYPE: ADMINISTRATIVE REVIEW:
[] New [] Current Guidance Used
[] Amendment [] References in Application Based On Current Regulations
[] Renewal [] All Attachments Referenced Included
[] Signature on Application ITEM 2: LEGAL IDENTITY NAME: ]
ITEMS 2 & 3: ADDRESS LOCATION OF DISTRIBUTION MAILING ADDRESS:
ADDRESS:
I ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION 1 CONTACT PERSON:
TELEPHONE NUMBER:
1 F-1 Draft NUREG - 1556, Vol.16
APPENDIX F ITEMS 5 & 6: MATERIAL TO BE DISTRIBUTED Item Isotope Mfg / Maximum Purpose of SSD Model No. Quantity Device. Registry per Device Number List as stated in application Defined in SSD registry yes/no yes/no yes/no yes/no yes/no certificate for a generally licensed device?
ITEMS 7,8,9 & 11: NOT APPLICABLE ITEM 10: RADIATION SAFETY PROGRAM Issue Suggested Response Provided? Yes/No Transfer Reports "We will provide quarterly transfer reports in accordance with 32.52(a) and (b)"
Recordkeeping "We will maintain records in accordance with 32.52(c)"
Information to "We will provide the appropriae information to Customers customers in accordance with 32.51a (a) and (b)
Draft NUREG - 1556, Vol.16 F-2
Appendix G ;
i Review Checklist for General Distribution. License Application (32.53) l l
E. .
IL l APPENDIX G Review Checklist for General Distribution License Application (32.53)
ITEM 1: ACTION TYPE ACTION TYPE: ADMINISTRATIVE REVIEW:
[] New [] Current Guidance Used
[] Amendment [] References in Application Based On Current Regulations !
[] Renewal [] All Attachments Referenced Included
[] Signature on Application ITEM 2: LEGAL IDENTITY NAME:
ITEMS 2 & 3: ADDRESS LOCATION OF DISTRIBUTION MAILING ADDRESS:
ADDRESS:
ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION CONTACT PERSON:
l TELEPHONE NUMBER:
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G-1 Draft NUREG - 1556, Vol.16
. o APPENDIX G ITEMS 5 & 6: MATERIAL TO BE DISTRIBUTED ltem Isotope Mfg / Maximum Purpose of SSD Model No. Quantity Device Registry Per Device Number ;
List as Stated in Application Defined in SSD Registry yes/no yes/no yes/no yes/no yes/no Certificate for a Generally Licensed Device?
ITEMS 7,8, 9 & 11: NOT APPLICABLE .
ITEM 10: RADIATION SAFETY PROGRAM lssue Suggested Response Provided? Yes/No Transfer Reports "We will provide annual transfer reports in accordance with.32.56" e
Draft NUREG - 1556, Vol.16 G-2 L
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Appendix H Review Checklist for General Distribution-License Application (32.57)
APPENDIX H Review Checklist for General Distribu.'. ion License Application (32.57)
ITEM 1: ACTION TYPE ACTION TYPE: ADMINISTRATIVE REVIEW:
[] New [] Current Guidance Used j
[] Amendment [] References in Application Based On Current Regulations '
[] Renewal [] All Attachments Referenced Included ,
[] Signature on Application
)
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ITEM 2: LEGAL IDENTITY l NAME:
ITEMS 2 & 3: ADDRESS LOCATION OF DISTRIBUTION MAILING ADDRESS:
ADDRESS:
ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION 1
CONTACT PERSON: l TELEPHONE NUMBER:
l H-1 Draft NUREG - 1556, Vol.16
r-
/SPENDIX H ITEMS 5 & 6: MATERIAL TO BE DISTRIBUTED Item Isotope Maximum Quantity Purpose of the Source per Source List as Stated in Application Defined in 32.57? AM-241 <5 microcuries Distribution for use under a GL of 31.8 (in calibration or reference sources)
YES/NO YES/NO YES/NO ITEMS 7,8,9 & 11: NOT APPLICABLE
]
Draft NUREG - 1556, Vol.16 H-2 I
U
. . 1 I
l APPENDIX H ITEM 10: RADIATION SAFETY PROGRAM Issue Suggested Response Provided? Yes/No Labeling (32.58) Submit an actual label that contains a statement, or a substantially similar statement with the following:
"The receipt, possession, use, and transfer of this i
source, Model , Serial No. . are subject to a i general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an I
agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS l SOURCE CONTAINS AMERICIUM -241. l DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
(Name of manufacturer or initial transferor)"
i I
i i
i H-3 Draft NUREG - 1556, Vol.16 E
l-I l
I Appendix l l
Review Checklist for General Distribution License Application (32.61) l l
1
r- . .
APPENDIX 1 Review Checklist for General Distribution License Application (32.61)
ITEM 1: ACTION TYPE ACTION TYPE: ADMINISTRATIVE REVIEW:
[] New [] Current Guidance Used
[] Amendment [] References in Application Based On Current Regulations
[] Renewal [] All Attachments ReferencedIncluded
[] Signatureon Application ITEM 2: LEGAL IDENTITY NAME:
ITEMS 2 & 3: ADDRESS LOCATION OF DISTRIBUTION MAILING ADDRESS:
ADDRESS:
ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION CONTACT PERSON:
TELEPHONE NUMBER:
l I-I Draft NUREG - 1556, Vol.16 L
1 APPD4 DIX I ITEMS 5 & 6: MATERIAL TO BE DISTRIBUTED Item Isotope Mfg / Maximum Purpose of SSD Model No. Quantity Device Registry per Device Number List as Stated in Application Defined in SSD Registry yes/no yes/no yes/no yes/no yes/no Certificate for a Generally Licensed Device?
ITEMS 7 - 11: NOT APPLICABLE Draft NUREG - 1556, Vol.16 I-2
GENERAL LICENSE DISTRIBUTION n% ,c DI r -
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p p g g u sc_ms nogg Figure 5.3 Static Eliminators. Certain static elimination devices and tritium-activatedsafety signs can bepossessed under 10 CFR 31.3.
Q 31.7 Luminous safety devices for use in aircraft
- Luminous safety devices containing only hydrogen-3 (tritium) or promethium-147.
- Tritium devices not to exceed 370 gigabequerels (GBq) (10 Ci) per device.
- Promethium-147 devices not to exceed 1I GBq (300 mci) per device.
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Figure 5.4 Luminous Exit Sign. Safety devices, such as luminous exit signs, containing tritium orpromethium-147 and used in aircraft may be used under 10 CFR 31. 7 generallicense.
5-5 Draft NUREG - 1556, Vol.16
9 8 I
GENERAL LICENSE DISTRIBUTION 6 31.8 Americium-241 in the form of calibration or reference standards
. Single source not to exceed 185 kilobequerels (kBq)(5.0 Ci) at any one time and/or location of use or storage.
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m Figure 5.5 Calibration Standards. Certain calibration andreferencedsources containing americium-241 can be possessed under a generallicense authori:ed in 10 CFR 31.8.
6 31.10 Strontium-90 in ice detection devices
. Single sources not to exceed 1,850 kBq (50 Ci) per source.
6 31.11 Bynroduct material for certain in vitro clinical or laboratory testine i
. Iodine-125 not to exceed 370 kBq (10 uCi)
. Iodine-131 not to exceed 370 kBq (10 Ci)
. Carbon-14 not to exceed 370 kBq (10 Ci)
. Hydrogen-3 not to exceed 1,850 kBq (50 uCi)
. Iron-59 not to exceed 740 kBq (20 Ci)
. Selemum-75 not to exceed 370 kBq (10 Ci)
. Mock iodine-125 not to exceed 1.85 kBq (0.05 Ci) ofiodine-129 and 0.18 kBq (0.005 uCi) of americium-241.
1 Draft NUREG - 1556, Vol.16 5-6
. o GENERAL LICENSE DISTRIBUTION ggg.hcyyQ myk3; ,
f TSH Thyroid Stimulatien Hormone k '
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In-vitro Kit .
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M5 Figure 5.6 In Vitro Kit. Certain in vitro kits usedin medicine, veterinary medicine, hospitals, and clinical laboratories are authori:ed in 10 CFR 31.11.
5.4 PROPRIETARY INFORMATION License applications are available for review by the general public in the NRC Public Document Rooms. Proprietary information as described in 10 CFR 2.790 (i.e., information not to be disclosed to the public) should not be included in an application unless necessary. Any proprietary or financial information submitted should be clearly marked by the applicant as
" Proprietary Information." In addition, the applicant must support the request to withhold by following the procedure in 10 CFR 2.790, "Public inspection, exemption, requests for withholding." Failure to follow this procedure may result in disclosure of the proprietary information to the public or substantial delays in processing the application.
Applications containing information marked as " Proprietary Information," will be reviewed to determine if this information is necessary to issue the license. If the information is determined unnecessary, it will be returned to the applicant. If such information is necessary to issue the license,it will be reviewed by the NRC to determine ifit is indeed proprietary or confidential and should be withheld from public disclosure.
If NRC determines that the application or affidavit is deficient, i.e., does not contain the required information as outlined in { 2.790(b)(a), the applicant will be notified that additional information is needed and that the review will continue when the required information is received.
Applicants will be informed that NRC must review the information before determining to withhold it from public disclosure and that the review of their request for licensing may continue. ;
A license cannot be issued until the request to withhold information is resolved.
5-7 Draft NUREG - 1556, Vol.16
z a GENERAL LICENSE DISTRIBUTION
'Once NRC has reviewed the application and affidavit and determined whether to withhold the ~
information from public disclosure, the Commission will notify the licensee by letter ofits decision and the appropriateness of their { 2.790 affidavit (see Appendix D). Appendix D also includes a checklist for requesti, for withholding the information.
Applicants should write " Proprietary Information" on the top and bottom of the front page of each document containing proprietary information. The license reviewer will place a Proprietary Information cover sheet (NRC Form 190) on the document.
Note: Additional procedures for the handling of proprietary information can be found in Directive 12.6 (formerly MC 2101),"NRC Sensitive Unclassified Information Security Program."
5.5 FOREIGN VENDORS Foreign vendors are unique in that NRC has nojurisdiction over the foreign entities. Pursuant to 10 CFR 110.53, " United States address, records, and inspections," foreign vendors or licensees involved in importing and exporting nuclear material and equipment are required to establish an address in the United States where papers may be served, where records can be maintained, and where the NRC can inspect the applicant's activities and records as necessary to accomplish its mission. Themfore, a general distribution license will not be issued to a foreign vendor unless the requirements set forth in {l10.53 have been satisfied. Specifically, the foreign entity must have a specified location of use within the United States of America.
c Draft NUREG - 1556, Vol.16 5-8
6 HOW TO FILE 6.1 PAPER APPLICATION Form 313 Applicants wishing to distribute or initially transfer products containing byproduct material to persons generally licensed under 10 CFR Part 31 should complete NRC Form 313, " Application for Material License" (Appendix B). An application for a distribution license should contain information concerning the distribution of radioactive material only (not possession and use).
Applicants for a materials license should do the following:
- Be sure to use the most recent guidance in preparing an application.
- Complete NRC Form 313 (Appendix B) Items I through 4,12, and 13 on the form itself.
- Complete Items 5,6 and 10, as applicable, and attach separately.
- Items 7,8,9 and 11 are not applicable to distribution licenses.
- Submit all typed pages, sketches, or drawings on 8-1/2 x 11-inch paper to facilitate handling and review. Larger drawings should be folded to 8-1/2 x 11 inches.
- Avoid submitting proprietary infonnation unless it is absolutely necessary.
Submit an original, signed application and one copy.
- Retain one copy of the license application for future reference.
As required by 10 CFR 30.32(c), applications must be signed by a duly authorized representative; see Section 8.9, Certification of Application.
Using the suggested wording of responses and committing to using any model procedures in this draft report will expedite NRC's review.
Please note that ifit is necessary when filing for a license to reference information contained in other licensees' file (s) or registration certificate (s) :urrent, retired or inactive, the information should be submitted, in its entirety, as part of the application.
All license applications will be available for review by the general public in NRC's T eblic Document Rooms. Ifit is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, Social Security Number, date of birth, 6-1 Draft NUREG - 1556, Vol.16
HOW TO FILE and radiation dose information, should not be submitted unless specifically requested by NRC.
See Section 5.4, Proprietary Information, for guidance.
As explained in the Foreword, NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will )
continue to accept paper applications. However, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:
. Submit printed or typewritten, not handv/ritten, text on smooth, crisp paper that will feed easily into the scanner.
. Choose 12-point or larger font size.
. Avoid stylized fonts (or type faces) such as senpt, italic, etc.
. Be sure the print is clear and sharp.
. Be sure there is high contrast between the ink and paper (black ink on white paper is best).
6.2 ELECTRONIC APPLICATION As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or CD-ROM, and through the Internet. Additional filing
. instructions will be provided as these new mechanisms become available. The existing paper process will be used until the electronic process is available.
6.3 WHERE TO FILE Applicants wishing to distribute or initially transfer products (containing byproduct material to persons generally licensed under 10 CFR Part 31, or equivalent Agreement State regulations) from any State or U.S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office in the locale from which the material will be distributed orinitially transferred. Figure 2.1 in Section 2 shove NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States.
In general, applicants wishing to distribute or initially transfer such products from a location in an Agreement State must file an application with the Agreement State, not NRC. See Section 2,
. Agreement States, for additional information.
Requests for safety evaluations of sealed sources or devices are submitted directly by applicants to the Division ofIndustrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Draft NUREG - 1556, Vol.16 6-2
r: .
(L HOW TO FILE '
- Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 (address is also found at the top ofNRC Form 313).
I i-
?.
6-3 Draft NUREG .1556, Vol.16
7 APPLICATION AND ANNUAL FEES Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31, " Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses," to determine the amount of the fee that must accompany your application. NRC will not issue the new license prior to fee receipt. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application.
For applicants wishing to distribute items containing byproduct material pursuant to { 31.3, 31.5,31.7 and 31- 10 that require a source or device evaluation, the fee categories are 3B for possession and use license,3J for distribution license, and 9A for the device evaluation or 9C for source evaluation. For applicants wishing to distribute items pursuant to (( 31.8 and 31.11 that do not require a source or device evaluation, the fee categories are 3B for possession and use and 3K for distribution.
Most NRC licensees are also subject to annual fees; refer to { 171.16; the same fee categories that applied to the application, amendment, renewal and registration fees also apply to the annual fees. Consult { 171.11 for additional information on exemptions from annual fees and
{ 171.16(c) on reduced annual fees for licensees that qualify as "small entities."
Direct all questions about NRC's fees or completion ofItem 12 of NRC Form 313 (Appendix B) j to the Office of the Chief Financial Officer (OCFO) at NRC headquarters in Rockville, Maryland j (301) 415-7554. As an altemative, call NRC's toll free number, (800) 368-5643 and then ask for extension 415-7554.
Payment of fees chould be mailed along with the application (s) to the Division ofIndustrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear !
Regulatory Commission, Washington, DC 20555 0001. ;
NRC conducts rulemaking each year to establish the Part 171 annual fees and to make any l necessary changes to the Part 170 licensing and inspection fees. The proposed changes to the fees are published in the Federal Recister for public comment, and a copy of the proposed rule is mailed to all licensees. After consideration of the comments received, a final rule is published in j the Federal Recister and a copy mailed to all licensees. At that time, invoices are issued for the f ' annual fees. Although the invoices are issued for the full amount of the annual fee, the amount due may be reduced as provided in { 171.16(c) if the licensee qualifies as a small entity under NRC's size standards and so certifies by completing and retuming NRC Form 526,"Small Entity Certification," which is enclosed with each annual fee invoice. A new c.:rtification is required to be submitted with the annual fee payment each year.
7-1 Draft NUREG - 1556, Vol.16
8 CONTENTS OF AN APPLICATION The following comments apply to the indicated items on NRC Form 313 (Appendix B).
8.1 ITEM 1: LICENSE ACTION TYPE THIS IS AN APPLICATION FOR (Check appropriate item)
Type of Action License No.
[ ] A. New License Not Applicable
[ ] B. Amendment XX-XXXXX-XX
[ ] C. Renewal XX-XXXXX-XX l
~
Check box A for a new license request.
Check box B for an amendment' to an existing license, and provide license number.
Check box C for a renewal' of an existing license, and provide license number.
8.2 ' ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS List the legal name of the applicant's corporation or other legal entity with direct control over the distribution of the radioactive material (product); a division or depam tent within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the distribution of the radioactive material (product) is not .
connected with employment in a corporation or other legal entity. Provide the mailing address I where correspondence should be sent. A Post Office Box number is an acceptable mailing address.
Note: While a U.S. address is required in order to issue a license, it is acceptable for the licensee's mailing address and the state code in the license number to be based on an address ,
located in Puerto Rico, Canada, or the U.S. Virgin Islands. !
Notify NRC of changes in mailing address; these changes do not require a fee.
See Section 11, Amendments and Renewals to a license. Licensees may request an amendment to an existing license to add changes or modifications to their existing radiation safety procedures, location of use, name of l Radiation Safety Officer, etc.
8-1 Draft NUREG - 1556, Vol.16
e as
.' CONTENTS OF AN APPLICATION Note: NRC must be notified before control of the license is transferred, and the licensee must receive written consent from the NRC prior to the change of control. NRC must also be notified when bankruptcy proceedings have been initiated. See below for more details. NRC Information Notice (IN) 97-30, " Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3,1997, discusses the potential for the security and control oflicensed material to be compromised during periods of organizationalinstability.
NUREG 1556, Volume 15, Consolidated Guidance About Materials Licenses; Guidance About Changes of Control and Bankruptcy Involving Byproduct, Source, or Special Nuclear Material Licenses, provides additional information about NRC requirements related to both changes of control and bankruptcy.
8.2.1 TIMELY NOTIFICATION OF TRANSFER CONTROL Regulations: 10 CFR 30.34(b).
Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license.
Discussion: Control over licensed activities can be constmed as the authority to decide when and how that license (licensed material and/or activities) will be used. A change of ownership may be an example of a change of control, depending on whether the authority over the license has been transferred from one person to another. For example, a change may result from a merger or buyout. The transfer of stock or other assets is not a change of control, unless there is a change of authority over the license.
It is not NRC's intent to interfere with the business decisions oflicensees. NRC will require licensees to submit only such business information as is necessary to permit the Commission to determine whether a change of control will take place. This information is required to ensure that all NRC requirements are followed.
Response from the Applicant: None from an applicant for a new license; Appendix E, excerpted from IN 89-25 (Rev.1)," Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994, identifies the information to be provided about changes of control.
Draft NUREG - 1556, Vol.16 8-2
. e l
l CONTENTS OF AN APPLICATION
Reference:
See the Availability Notice on the inside frant cover of this draft report to obtain copies of:
a information Notice 89-25 (Rev.1), " Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994;
. Information Notice 97-30," Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3,1997.
Information Notices are available on NRC's website at <www.nrc. gov /NRC/ reference.html>.
8.2.2 NOTIFICATION OF BANKRUPTCY PROCEEDINGS Regulations: 10 CFR 30.34(h).
Criteria: Immediately following filing of voluntary or involuntary petition for bankruptcy for against a licensee, specific licensees and certain general licensees must notify the appropriate NRC Regional Administrator,in writing, identifying the bankruptcy court in which the petition was filed and the date of filing.
Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains
. responsible for all regulatory requirements. NRC needs to know when licensees are in i bankruptcy proceedings in order to determine whether all NRC requirements are followed prior to the completion of the bankruptcy actions. NRC shares the results ofits determinations with other involved entities (e.g., trustee) so that health and safety issues can be resolved before bankruptcy actions are completed.
1 Response from Applicant: No response is required at time of application for a new license. 1 Generally, licensees should notify NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of filing a bankruptcy petition.
Reference:
See the Availability Notice on the inside front cover of this draft report to obtain copies of:
. Inspection Procedure 87103," Inspection of Material Licensees Involved in an Incident or Bankruptcy Filing."
Inspection Procedure 87103 is available on NRC's website at <http://www.nrc. gov >.
Additional
References:
. Policy and Guidance Directive PG 8-11,"NMSS Procedures for Reviewing Declarations of ;
l Bankruptcy," dated August 8,1996.
l 8-3 Draft NUREG - 1556, Vol.16 m l
CONTENTS OF AN APPLICATION 8.3 ITEM 3: ADDRESS (ES) FROM WHICH LICENSED MATERIAL WILL BE DISTRIBUTED An applicant for a general distribution license must be an organization with an address in the United States from which it will distribute the items. The applicant must specify the street address, city, and state or other descriptive address (e.g., on Highway 10,5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for cach and every facility used as a location from which distribution will occur. A Post Office Box address is not acceptable. Each point of distribution will be listed on the general distribution license.
Being granted an NRC license does not relieve a licensee from complying with other applicable Federal, State, or local requirements (e.g., local zoning requirements or local ordinances requiring registration of radioactive material).
8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION Identify the individual who can provide information and answer questions about the application and the product (s) to be distributed, and include his or her telephone number. This is typically the RSO, unless the applicant has named a different person as the contact. The NRC will contact this mdividual if there are questions about the application.
Notify the NRC if the contact person or his or her telephone number changes so that the NRC can contact the applicant or licensee in the future regarding questions, concerns, or information.
Notification of a contact change is for information only and would not be considered an application for license amendment.
The individual named in Item 4 of the application may or may not be the same individual who signs the application as the " certifying official" on behalf of the licensee and has the authority to make commitments to NRC (see Item 13 on Form 313, Appendix B). Any commitments made by the applicant should be signed by the individual named in Item 13 since only that individual is considered by NRC to have the authority to make commitments on behalf of the applicant. NRC will not, therefore, accept license amendments or renewals signed by the individual identified in Item 4, if this person differs from the one named in Item 13.
The NRC recognizes that licensees may use a consultant or consultant group to help prepare the license application and provide support to the radiation protection program. Licensees are reminded that regardless of the role of the consultant in radiation protection program management, the licensee remains ultimately responsible for all aspects of the licensed program, including the services perfonned by the consultant.
Draft NUREG - 1556, Vol.16 8-4
. e l
l CONTENTS OF AN APPLICATION ' !
8.5 ITEM 5: RADIOACTIVE MATERIAL AND PURPOSES FOR i WHICH LICENSED MATERIAL WILL BE USED Regulations: 10 CFR 30.33; 10 CFR 32.f1; 10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71.
Criteria: An application for a general distribution license will be approved if the requirements of 10 Cl R 30.33, and the applicable requirements of 10 CFR 32.51,10 CFR 32.53, 10 CFR 32.57,10 CFR 32.61 and/or 10 CFR 32.71 are met.
Discussion: Applicants should determine what devic es or products are to be distributed and provide information about each type of product. Describe in general terms the purpose of each product. Activity should be specified in terms of"XX becquerels (YY curies)." For example, "the maximum activity per sealed source is 370 MBq (10 mci) of cesium-137."
A safety evaluation of sealed sources and devices is required on certain generally licensed devices. This evaluation is performed by NRC or an Agreement State before authorizing a manufacturer (or distributor) to distribute the device to general licensees. The safety evaluation is documented in an SSD Rettistration Certificate. Information on SSD registration certificates is available on the NRC's we?. site at <http //www.hsrd.ornl. gov /ntc/ssdrform.htm> and may also be obtained by contacting the Registration Assistant by calling NRC's toll free number, (800) 368-5642, Extension 415-7231. For additional guidance relating to sealed sources and devices, see also NUREG-1556, Vol. 3, " Applications for Sealed Source and Device Evaluation and Registration."
Response from Applicant: The applicant should provide the following for each device to be .
distributed: )
- Isotope
- Manufacturer and model number Maximum activity per device
. Purpose of the device
. SSD Registration Certificate Number for devices that have been through the evaluation and registration process, if applicable. For devices that do not have registry numbers, provide the required information addressed in NUREG-1556, Vol. 3, for each device / product to be distributed.
References:
See the Availability Notice (on the inside front cover of this draft repon) to obtain a copy of NUREG-1556, Vol. 3," Consolidated Guidance about Materials Licenses: Applications 8-5 Draft NUREG - 1556, Vol.16
CONTENTS OF AN APPLICATION for Sealed Source and Device Evaluation and Registration." Also, see the Sample Registration Certificates for Generally Licensed Products, in Appendix C to this document.
8.6 ITEMS 7,8,9 & 11: NOT APPLICABLE These items on form 313 are not applicable for general distribution licenses.
8.7 ITEM 10: RADIATION SAFETY PROGRAM (REQUIREMENTS FOR A GENERAL DISTRIBUTION LICENSE) 8.7.1 10 CFR 32.51: REQUIREMENTS FOR INITIAL TRANSFER OF DEVICES FOR USE UNDER 10 CFR 31.5 Regulations: 10 CFR 31.5,10 CFR 32.52.
Criteria: Applicants for a specific license to distribute generally licensed devices specified in 31.5 should provide sufficient information relative to the material transfer reports and records.
Applicants should supply copies ofinformation packet to be sent to customers before transfer.
Discussion: The following information must be submitted or addressed as part of the license application.
. Quarterly material transfer reports Licensees are required to file a report with the NRC within 30 days of the end of each calendar quarter in accordance with 10 CFR 32.52. Appendix P contains Form XXX, entitled
" Transfers ofIndustrial Devices Report." This form may be used to submit these quarterly reports. Alternatively, the licensee may use another report format as long as the report includes the following:
- Name and license number of the specific licensee submitting the report.
- Name and address of each General Licensee to which a product was transferred.
This address is to be the mailing address of the place of use of the device. For devices that are portable, this address should be the mailing address of the primary place of storage of the device. For the case where a customer has multiple locations of use, each location of use should be listed as a separate transfer with the corresponding mailing address of each location of use (unless the multiple locations are contained within the same business campus or industrial complex). For example, if Company A owns Coal Fired Power Draft NUREG - 1556, Vol.16 8-6
O O CONTENTS OF AN APPLICATION Plants in two different locations with generally licensed gauges, there are two general licenses granted to Company A, and each general license is for a different location of use.
Reports to the NRC should only include transfers of devices where the place of use is in an NRC State, or for portable devices, the primary place of storage of the device is in an NRC
-State.
- Name and phone number of each General Licensee's responsible inoividual (RI).
The RI is required to be an individual designated by the General Licensee to be responsible for having knowledge of and authority to'take required actions to ensure the day-to-day compliance with the appropriate regulations and requirements in & 31.5. Each General Licensee must designate one RI per location and cannot designate more than one RI per location. An RI can however be assigned to more than one general license. This individual is not necessarily someone who works onsite at the place of use of the device and is not necessarily conducting all required actions, but is responsible to ensure that required actions are taken.
- Date of transfer.
- Type, model number, and serial number of each product transferred.
- Quantity and type of byproduct material contained in the product.
In addition:
If one or more " intermediate persons" will temporarily possess the device at the intended place of use prior to the intended user taking possession, the report must include the same information for each intermediary, and s arly designate that person as an intermediate person. The term "intennediate persons" means a person, company, or corporation that will temporarily possess the device at an intended place of use prior to its possession by the intended user. Note that an intermediate person cannot hold a device in storage for longer than two years.
If the product transferred replaced another returned by the General Licensee, the report must note this and include the type, model number, and serial number of the product returned.
If no transfers were made during the reporting period, a report of no activity is required.
Licensees must also submit a report containing the same information outlined above to the responsible Agreement State agency for transfers to general licensees in Agreement States.
However, a report of no transfers is only required if an Agreement State requests it.
8-7 Draft NUREG - 1556, Vol.16
CONTENTS OF AN APPLICATION
. Recordkeeping Records of all f 31.5 transfers, including all information required in the above reports and records of final disposition, are required to be maintained for 3 years after the expected useful life of the' device or the final disposition of the device, if known.
Licensees are required to make available, upon request, to the various regulatory agencies, records of final disposition of devices in the event the licensee files for bankruptcy or requests termination of the license.
Appendix K of this guide supplies additional guidance that may be sent to general licensees.
This guidance will assist these licensees on common questions they may have and it describes their requirements in a concise form.
- Information to be supplied to customers Licensees are required to provide information to their generally licensed customers before transfer of devices in accordance with 10 CFR 32.51a (a) and (b). The intent is for the customer to be aware of this information prior to making a conunitment to purchase, i.e., so that they can consider the requirements associated with the general license and the costs of disposal of the device in making a decision to purchase.
- 1. a copy of 10 CFR 31.2,31.5,20.2201, and 20.2202
- 2. a list of services that can only be performed by a specific licensee
- 3. information on acceptable disposal optione and estimated cost of disposal If the customer is planning to use the device in an Agreement State, a copy of applicable state regulations and the name, address, and phone number of the contact at the Agreement State regulatory agency should be provided. A copy of NRC regulations listed in item 1 above can be substituted for the Agreement State regulations with a note that the device is regulated by the Agreement State regulations.
Response from Applicant: Submit the following:
"We will provide quarterly transfer reports in accordance with & 32.52(a) and (b) and will maintain records in accordance with 32.52(c). We will provide information to customers prior to purchase in accordance with @ 32.51a (a) and (b)."
References:
Appendix F contains a checklist for use in reviewing general distribution license applications for @ 31.5 devices. Appendix K contains guidance for General Licensees. Appendix P contains a form for use in submitting quarterly material transfer reports.
Draft NUREG - 1556, Vol.16 8-8
CONTENTS OF AN APPLICATION 8.7.2 10 CFR 32.53: REQUIREMENTS FOR INITIAL TRANSFER OF LUMINOUS SAFETY DEVICES FOR USE IN AIRCRAFT Regulations: 10 CFR 31.7,10 CFR 32.53,10 CFR 32.56.
Criteria: Applicants for a specific license to initially transfer luminous safety devices for use in aircraft containing tritium or promethium-147 for distribution to general licensees under @ 31.7 must provide sufficient information relative to annual material transfer reports. All devices distributed under 10 CFR 31.7 require a SSD review.
For products distributed to general licensees pursuant to 31.7, the specific licensed distributor is required under { 32.56 to file an annual report with the NRC before July 30 of each year covering the year ending June 30. The report must include:
. Name of each general licensee to which a pruauet was transferred (distributed);
. Types and numbers of each product transferred (distributed);
. Quantity of tritium or promethium-147 contained in each type of product; and
. Total quantity of tritium or promethium-147 transferred (distributed).
The report should also identify the specific licensee submitting the report (the distributor) and the specific license number.
Response from Applicant: Submit the following:
"We will provide annual material transfer repons in accordance with { 32.56."
References:
Appendix G contains a checklist for ute in reviewing a general diedbution license application for luminous safety devices for aircraft.
8.7.3 10 CFR 32.57: REQUIREMENTS FOR INITIAL TRANSFER OF CAllBRATION OR REFERENCE SOURCES CONTAINING AMERICIUM-241 '
Regulations: 10 CFR 31.8,10 CFR 32.57; 10 CFR 32.58.
Criteria: Applicants for a specific license to initially transfer calibration or reference sources containing americium-241 for distribution to persons generally licensed under G 31.8 must provide sufficient information relative to % 32.57 and 32.58. A sealed source and device (SSD) 8-9 Draft NUREG - 1556, Vol.16
CONTENTS GF AN APPLICATION registration certificate is not required for americium-241 calibration sources that contain less than 185 kBq (<5.0 microcuries).
Discussion: This section outlines the requirements to obtain a license for an applicant wishing to distribute americium-241 reference and calibration sources.
The byproduct material must be prepared for distribution in calibration or reference sources consisting of americium-241 not exceeding 185 kBq (5.0 microcuries).
Each source or storage container for the source must bear a label which contains the following statement (or a substantially similar statement):
The receipt, possession, use, and transfer of this source, Model . Serial No. . are subject to a generallicense and the regulations of the United States Nuclear Regulatory Cornrnission or of a State with which the Corrmssion has entered into an agreernent for the exercise of regulatory authority. Do not rernove this label.
CAUTION RADIOACTIVE MATERIAL THIS SOURCE CONTAINS AMERICIUM-241.
DO NoT TOUCH RADIOACTIVE portion OF THIS SOURCE.
[Name of manufacturer or initial transferor)
REN Figure 8.1 Gauge Label.
Response from Applicant: Submit an actual label for each americium-241 check or reference source to be distributed. These labels must contain the information as described in the Discussion section above.
Reference:
Appendix H contains a checklist for use in reviewing a general distribution license application for americium-241 calibration or reference sources under s 31.8.
8.7.4 10 CFR 32.61: REQUIREMENTS FOR INITIAL TRANSFER OF ICE DETECTION DEVICES CONTAINING STRONTIUM-90 Regulations: 10 CFR 31.10,10 CFR 32.61.
Criteria: Applicants for a specific license to initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under @ 31.10 must only provide sufficient information relative to Items 1 through 6 of NRC Form 313. An SSD review is required.
Response from Applicant: No specific response required.
Draft NUREG - 1556, Vol.16 8-10
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CONTENTS OF AN APPLICATION l
References:
Appendix I contains a checklist for use in reviewing general distribution license applications for ice detection devices.
I 8.7.5 10 CFR 32.71: REQUIREMENTS FOR INITIAL TRANSFER /N V/TRO KITS UNDER 10 CFR 31.11 Regulations: 10 CFR 20.1901(a),10 CFR 20.2001,10 CFR 31.11; 10 CFR 32.71.
Criteria: Applicants for a specific license to initially transfer byproduct material for certain in vitro clinical or laboratory testing for distribution to persons generally licensed under 31.11 must provide sufficient information to satisfy {32.71(b)-(e). l Discussion: This section outlines the requirements to obtain a license for an applicant requesting ,
authorization to distribute in vitro kits to persons who use them for a variety of clinical tests such !
as Schillings tests, red cell survival tests, hormone evaluations and thyroid stimulating hormone tests (TSH). An SSD review is not required. '
l The byproduct material must be prepared for distribution in prepackaged units consisting of any of the following: )
Iodine-131, iodine-125, carbon-14, or selenium-75 not exceeding 370 kilobecquerels (kBq)
(10 Ci)
. Hydrogen-3 not exceeding 1,850 kBq (50 Ci)
. Iron-59 not exceeding 740 kBq (20 Ci)
. Mock iodine-125 not exceeding 1.85 kBq (0.05 Ci) ofiodine-129 and 0.18 kBq (0.005 Ci) of americium-241.
Each prepackaged unit must bear a durable, clearly visible label with the following wording:
. The radionuclide and chemical fonn
. A statement that the radioactivity does not exceed the limit indicated above for each radionuclide
. The radiation caution symbol described in {20.1901(a)
. The words, " Caution - Radioactive Material," and "Not for Internal or External Use in Humans or Animals."
- 8-11 Draft NUREG - 1556, Vol.16
CONTENTS OF AN APPLICATION Each package must also have a statement, or a substantially similar statement, that contains the following information on a label affixed to the prepackaged unit or in a leaflet or brochure accompanying the package:
The radioactive matenal may be received, acquired, possessed, and used only by physicians, vetennarians in the practice of vetennary rnedicine, clinical laboratones or hospitals and only for in vitro clinical or laboratory tests not involving intemal or extemal admir'istration of the material. or the radiation therefrom, to human beings or animals.
Its receipt, acquisition, possession, use and transfer are subject to the regulations and a generallicense of the U.S.
Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authorrty.
[Name of manufacturer]
'"TE Figure 8.2 Package Label.
This label or leaflet / brochure must contain adequate information as to the precautions to be observed in handling and storing such byproduct material. Regarding Mock lodine-125 reference / calibration sources, the information must also contain directions on disposing of waste in accordance with 20.2001. Usually, compliance with this requirement is achieved by transfer to an authorized recipient. In accordance with 10 CFR 31.11(f), except for mock iodine-125 sources, these licensees are exempt from the requirements in 10 CFR Parts 19,20, and 21, including the requirements on disposal oflicensed material. The distribution licensees may wish to infomt their customers of this exemption.
Response from Applicant: Submit an actual package label and/or leaflet / brochure for each type ,
of prepackaged kit. These labels and/or leaflet / brochures must contain the information as }
described in the Discussion section above.
The distributor of generally licensed in vitro kits must not transfer materials to a general licensee unless a properly completed NRC Form 483 is on file.
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References:
Appendix J contains a checklist for revieving general distribution license l applications for certain in vitro kits under 10 CFR 31,11.
8.8 ITEM 12: FEES On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application. Applicants should be aware that they may be responsible for fees in each category applicable to their application or license. Refer to Section 7 for more information.
Draft NUREG - 1556, Vol.16 8-12
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l CONTENTS OF AN APPLICATION NRC may begin review oflicensing requests without the proper fees; however, NRC will not issue a new license, amendment, renewal, or registration certificate prior to receipt of the appropriate fee.
l 8.9 ITEM 13: CERTIFICATION OF APPLICATION Individuals acting in a private capacity are required to date and sign NRC Form 313. Otherwise, representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. Representatives signing an application must be authorized to make binding commitments and to sign officialdocuments on behalfofthe applicant. As discussed previously in " Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applicationsforproper signature.
Note:
= When the application references commitments, those items become part of the licensing j conditions and regulatory requirements.
. It is a violation of 10 CFR 30.9 and 10 CFR 30.10 to make a false statement on an application.
Civil sanctions, including revocation of the license and/or orders removing individuals from licensed activity, may be taken.
- It is a criminal offense to make a willful false statement or representation on applications or I correspondence (18 U.S.C.1001).
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F 9 DEFICIENCY IN THE APPLICATION If, in the process of evaluating an application, it is determined that insufficient information has been submitted, the license reviewer will contact the applicant to obtain the necessary information. Depending on the type and complexity of the information needed, the reviewer may request the additional information through a formal written request or, especially for simple answers and clarifications, via telephone or electronic mail. Submittal of an inadequate or deficient application may delay the issuance of the license. The application could be rejected by the NRC for failure to provide a prompt or timely response to a deficiency in the application.
Applicants may request an extension of time in order to respond to any correspondence or request for additional information about its application, provided it is determined that there is good cause and the additional time is reasonable. The request may be in writing or via the telephone. Typically, the reviewer notifies the applicant by telephone that an extension has been granted with the new proposed date.
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10 ISSUANCE OF A LICENSE l
Licenses authorizing distribution of generally licensed products or devices under { 32.51,32.53, 32.57,32.61, and/or 32.71 are prepared using NRC Form 374 (see Appendix M for a typical example). This is a separate license from the possession and use license, and it is commonly referred to as a " General Distribution" license. All general distribution licenses include the following:
. Licensee's name and mailing address License number, docket number and expiration date (all assigned by NRC)
Byproduct material and its chemical and/or physical form
. Authorized use Products and maximum activity per source or device
. Locatian(s) from which generally licensed products may be distributed a
Condition that "this license does not authorize possession or use oflicensed material."
The general distribution license also contains a " tie-down" condition which commits the licensee to conducting its program in accordance with the statements, represcitations, and procedures ;
l contained in the documents, including any enclosures, submitted by the applicant.
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10-1 Draft NUREG - 1556, Vol.16
6- .
11 AMENDMENTS AND RENEWALS TO A LICENSE It is the licensee's obligation to keep the license current and anticipate the need for a license amendment. If any of the information provided in the original application needs to be modified or changed, the licensee should consult the appropriate Regional Office to determine if an amendment to the license is required and if required, the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date (10 CFR 2.109,10 CFR 30.36(a)).
For applications for license amendment, in addition to the following, the licensee must provide the appropriate fee. For renewal and amendment requests, applicants must do the following:
Be sure to use the most recent guidance in preparing an amendment or renewal request.
Submit, in duplicate, either an NRC Form 313 and/or a letter requesting amendment or renewal.
Provide the license number.
In requesting renewal of a license, licensees should do the following:
Review the current license and associated documents submitted to the NRC in the past to determine if the information is up to date and accurately represents the current licensed activities and products. Identify in the application, by date, those documents that are applicable and those that are out-of-date or superseded and indicate any changes necessary to reflect the cunent program.
Using the suggested wording of responses and committing to using any model procedures in this draft report will expedite NRC's review.
Applications for license renewal filed at least 30 days before the expiration date of the license will receive a " Deemed Timely" letter (see Appendix N for an example) confirming that the application has been timely filed and the present license will remain in effect until the NRC takes final action on the renewal application. A copy of this letter should be maintained until the amended license is received. If a renewal application is not received by the NRC before the expiration date, the licensee will be without a valid license when the license expires, at which point general distribution activities are no longer authorized and the licensee must cease all j
distribution activities until a new license can be obtained. The licensee must then submit an I application package for a new license.
Licensees not wishing to renew their general distribution license should send a letter to the NRC before the expiration date of the license with a request that the license be terminated (see Section 13 for additional guidance).
11-1 Draft NUREG - 1556, Vol.16
AMENDMENTS AND RENEWALS TO A LICENSE Amending or changing the general distribution license may also require amendments to the possession and use license (s) and/or the device registration sheet (s) for additions, deletions, or modifications to models of sealed sources or devices to be distributed.
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p 12 APPLICATIONS FOR EXEMPTIONS Regulations: 10 CFR 19.31,10 CFR 20.2301 and 10 CFR 30.11.
Criteria: Licensees may request exemptions to regulations. The licensee must demonstrate that the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest.
Discussion: Various sections of NRC's regulations address requests for exemptions (e.g.,10 CFR 19.31,10 CFR 20.2301,10 CFR 30.11(a)). These regulations state that the NRC may grant an exemption, acting on its own initiative or on an application from an interested person. Key considerations are whether the exemption is authorized by law, will endanger life or property or the common defense and security, and is otherwise in the public interest.
Until NRC ha granted an exemption in writing, NRC expects compliance with all applicable regulations.
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Exemptions are not intended for large classes oflicenses and are generally limited tc a unique l
situation. Exemption requests must be accompanied by descriptions o.f the following:
i a
Request for the exemption and explanation of why it is needed; Proposed compensatory safety measures intended to provide a level of health and safety equivalent to the regulation for which the exemption is being requested; a
Alternative methods for complying with the regulation and why they are not feasible.
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13 TERMINATION OF ACTIVITIES Regulations: 10 CFR 30.36.
Criteria: Termination of distribution activities.
Discussion: Pursuant to 10 CFR 30.36, general distribution licensees may request termination of their NRC license at any time. Licensees should notify NRC within 60 days of their decision to permanently cease licensed activities or the lack oflicensed activities for 24 months.
General distribution licensees that intend to terminate their possession and use activities as well are also responsible for notifying the appropriate NRC or Agreement State authorities conceming the disposition of the possession license and all radioactive material, and for providing records of deposition of all radioactive material, etc. to NRC or the Agreement State.
A license is not terminated until NRC takes final action to terminate the license; therefore, an application for license termination does not relieve the licensee from its obligations to comply with NRC regulations and the terms and conditions of the license until such time as the license is terminated in writing by NRC.
Response from Applicant: All categories of general distribution licenses require that product transfer reports be filed when discontinuing activities authorized under the license for the period of time between the filing of the preceding report and the request to terminate the license. If no l transfers of byproduct material have taken place, then the report should so indicate.
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Appendix A List of Documents Considered in Development of this Draft NUREG
APPENDIX A' List of Documents Considered in Development of this Draft NUREG This report incorporates, updates, and supersedes previous guidance found in Infonnation i Notices, " Standard Review Plan for Use of Sealed Sources in Nonportable Gauging Devices,"
and Technical Assistance Requests us it apph to manufacturing and initial distribution of generally licensed devices / products for use under 10 CFR 31. All superseded documents have been marked by an asterisk (*).
Table A.1 List of Documents Considered in the Preparation of this Report
=
Document Title Date l Identification IL 81-2* Interpretive Letter 81-2 5/4/81 IN 81-37' Information Notice 81-37, " Unnecessary Radiation Exposure to the 12/18/81 Public and Workers During Events Involving Thickness and Level Measuring Devices" IN 87-37* Information Notice 87-37, " Compliance with the General License 8/10/87 Provisions of10 CFR Part 31" IN 88-02* Information Notice 88-02, " Lost or Stolen Gauges" 2/2/88 IN 88-90* Information Notice 88-90, " Unauthorized Removal ofIndustrial 11/22/88 Nuclear Gauges" W 94-15* Information Notice 94-15, " Radiation Exposures During an Event 3/2/94 Involving a Fixed Nuclear Gauge" FC 85-04* Policy and Guidance Directive, " Standard Review Plan (SRP) for 2/6/85 Applications for Use of Sealed Sources in Nonportable Gauging Devices" FC 85-08* Policy and Guidance Directive, " Licensing of Fixed Gauges and 6/29/88 Similar Devices," Revision 1 i
A-1 Draft NUREG - 1556, Vol.16 i
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Appendix B United States Nuclear Regulatory Commission Form 313
e 4 NRC FORM 313 U, S. NUCLEAR REGULATORY COMMISSION APPROVED sY OMe: NO. 31504120 EXPIRES: Tr31/1999 (5-1997) to CF3 30. 32, 33 Eshmated tnaden per response lo comply we the firmaban cmeschcn request 7 hours8.101852e-5 days <br />0.00194 hours <br />1.157407e-5 weeks <br />2.6635e-6 months <br />. Submittal of the apphcaten a necessary to determ no that
- u. 35. a n ano0 = apphcen . uswied and ink adequoi. Pnodu,es .- i woiad in.
pelu: heelsh and safety Forward commerts regardrig tasden estanale to the Irvormataan and Records Managemen1 Brere (T4 F33). U S Nuclear APPLICATION FOR MATERIAL LICENSE "*a"-v c""""'** ***"a'* c 2 555**' *"d 'a '"' P'a*'*a'*
Reduchon Proled (3154 0120), Office of Management and Budget.
Washingtoit DC 20503 NRC may not condud or sponsor, and a person a not required to respond to, an riformahon collection unless it displays e curently vehd OMB control number INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.
APPUCATION FOR DISTRiSUTION OF EXEMPT PRODUCTS FILE APPUCATIONS WITH: IF YOU ARE LOCATED IN:
DMSION OF NOUSTRLAL AND MEDICAL NUCLEAR SAFETY ILUNotS, INDLANA, IOWA, MICHIGAN, MINNESOTA, MISSOUR1, OHBO, OR Wl0 CON $lN.
CTFCE OF HUCLEAR MATERALS SAFETY AND SAFEGUARDS SEND APPUCATIONS TO:
U S NUCLEAR REGULATORY COMMIS$ON WASHNGTON, DC 205554001 MATERIALS UCENSMG SECTION ALL OTHER PERSONS FILE APPUCATIONS AS FOLLOWS:
C SS REW m 801 WARRENVILLE RD.
IF YOU ARE LOCATED IN: USLE, IL 60532-4351 CONNECTICUT, CELAWARE, DISTRICT OF COLUMBIA, MAINE, MARYLAND, ALASKA, AR1 ZONA, ARKANSAS, CAUFORNIA, COLORADO, HAWAll, IDAHO, KANSAS.
MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, NEW YORK, PENNSYLVANIA, LOUISIANA MONTANA, NEBRASKA, NEVADA, NEW MEXCO, NORTH DAKOTA, RHODE ISLAND, OR VERMONT, SEND APPUCATIONS TO: OKLAHOMA, ORECOM, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS, UTAH, WASHINGTON, OR WYOMNG, SEND APPUCATIONS TO:
LICENSNG ASSISTANT SECTON NUCLEAR M ATERIALS SAFETY BRANCH NUCLEAR MATERIALS LCENSING SECTON U S NUCLEAR REGULATORY COMMISSION, REGION 1 U S NUCLEAR PEGULATORY COMMISSION, REGON IV 475 ALLENDALE ROAD 611 RYAN PLAZA DRfVE, SUITE 400 KNG OF PRUSSIA PA 19406-1415 ARLINGTON, TX 76011 4064 ALAAAMA, FLORIDA, GEORGIA, KENTUCKY, MISSISSIPPI, NORTN CAROUNA, PUERTO IUCO, SOUTH CAROUNA, TENNESSIEE, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA, SEND APPUCATIONS TO.
ATLANTA FEDERAL CENTER U. S NUCLEAR REGULATORY COMMISSON, REGON ll 61 FORSYTH STREET. S W. SUITE 23T85 ATLANTA, GEORGIA 303C3-3415 PERSONS LOCATED IN AGREEMENT STATES SEND APPUCATIONS TO THE U.S. NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE UCENSED MATERLAL IN STATES SUBJECT TO U.S. NUCLEAR REGULATORY COMMISSON JulWSDICTIONS.
1.
]S IS AH APPUCATON f OR (Check appopnate som) 2. NAME AND MAILNG ADDRESS OF APPUCANT pncfwe Zspcode)
A NEW LICENSE B. AMENDMENT TO UCENSE NUMBER C. RENEWAL OF UCENSE NUMBER
- 3. ADORESS(ES)WHERE UCENSED MATERIAL WILL BE USED OR POSSESSED 4. NAME OF PERSON TO BE CONTACTED ABOUT THIS APPUCAflON TELEPHONE NUMBER SUBMIT ITEMS 5 THROUGH 11 ON 8-1/2 X 11" PAPER. THE TYPE AND SCOPE OF INFORMATON TC BE PROVIDED IS DESCRIBED. IN THE UCENSE APPUCATON GUOE.
- g. RADIOACTIVE MATERIAL a Element and mass number, ti chemcal and/or physcal form, and c mecomum amourt 6. PURPOSE (S) FOR WHCH LCENSED MATERIAL M.L BE USED.
whs:n we be possessed at any one tune
? INDMDUAL(3) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRANNG EXPERIENCE. 8 TRAINHG FOR lNDMDUALS WORKING IN OR FREOUENTNG RESTRICTED AREAS.
9 FACluTIES AND EOUIPMENT. 10. RADLATION SAFETY PROGRAM 12 UCENSEE FEES (See to CFR f 70 and Secoon f 70.3f)
ASTE NN FEE CATEGORY ED $
13 CERTIFCATION (Must be compidfod by aspecent) THE APPUCANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THl3 APPUCATON ARE BINDING UPON THE APPUCANT.
THE APPUCANT AND ANY OFFCIAL EXECUTNG THIS CERTIFICATION ON BEHALF OF THE APPLICANT, NAMED N TTEM 2. CERTIFY THAT THIS APPUCATION IS PREPARED IN CONFORMITY WITH TITLE 10. CODE OF FEDERAL REGULATIONS, PARTS 30,32,33,34,35,36. 39 ANO 40, AND THAT ALL INFORMATON CONTAINED HEREN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BEUEF.
WARMNG: 18 U S C. SECTON 1001 ACT OFJUNE 25,1948 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UN!TED STATES AS TO ANY MATTER WTTHIN ITS JURISOCTON CERT 7YNG OFFICER - T1PEDFRONTED NAME AND TITLE SIGNATURE DATE FOR NRC USE ONLY TYPE OF FEE FEE LOG FEE CATEGORY AMOUNT RECEIVED CHECK NUMBER COMMENTS S
APPROVED BY DATE NRC FORM 313 (51997) B-1 Draft NURLt"f1B95,Ryf{LgAPER
i Form XXX - Transfers of industrial Devices Report Page of l Nams of Vendor: Reporting Period:
l Lic:nse Number: From: To: l For etch " person" to whom a device (s) has been transferred duriag the reporting period, supply the following:
l Intermediate Person (if any) l Nam 3:
- and Street:
City, State, and Zip Code:
Nams of Responsible Individual: Telephone number:
l General Licensee User Information l
Name:
Department:
- and Street:
City, State, and Zip Code:
Nima of Responsible Individual: Telephone number:
l Information on Device (s) Transferred: l Dits of Transfer: / if Type of Device: Model Number: Serial number: Isotope: Activity and Units:
In the ccse of replacements, provide following for device (s) received:
Intermediate Person (if any)
Nime:
- cnd Street:
City, Stite, and Zip Code:
Nims of Responsible Individual: Telephone number:
l General Licensee User information l
NIme:
Department:
- End Street:
City, Sttte, and Zip Code:
Nime of Responsible Individual: Telephone number; l
Information on Device (s) Transferred: l D t3 of Transfer: / if Type of Device: Model Number: Serial number; Isotope: Activity and Units:
In the cise of replacements, provide following for device (s) d r:ceived:
p, , .. .. . . . . . . .
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ATTACHMENT 10 Draft NUREG-1556, Vol.16, Consolidated Guidance About Materia!s Licenses: Program-Specific Guidance About General License Distribution Licenses
l l NUREG-1556 Vol.16 Consolidated Guidance About Materials Licenses 1
Program-Specific Guidance About Licenses Authorizing Distribution To General Licensees Draft Report for Comment l Manuscript Completed: March 1999 l Date Published: March 1999 l Prepared by D. Wiedman, B. Parker, S. Minnick, J. McCausland l
Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
,2 - e e
t rABSTRACT As part ofits redesign of the materials licensing process, NRC is consolidating and updating
- numerous guidance documents'into a single comprehensive repository as described in NUREG-1539, " Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, " Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. Draft NUREG-1556, Vol.16,
" Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses
' Authorizing Distribution to General L,icensees," dated March 1999, is the sixteenth program-specific guidance document developed for the new process and is intended for use by applicants, specific and general licensees, and NRC staff. It also will be available to Agreement States.
The requirements for an NRC general license for persons who receive, possess, use, transfer, own, or acquire byproduct material in generally licensed products are' provided in 10 CFR Part 31, " General Domestic Licenses for Byproduct Material." The requirements to obtain an NRC general distribution nicense for persons who <listribute or initially transfer byproduct material in generally licensed products are provided in 10 CFR Part 32, " Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material."
Generally licensed products include static elimination devices, gauging devices, gas chromatograph detector cells, tritium signs, in-vitro clinical or laboratory kits, and check sources.
'Ihese devices /pmducts are distributed to general licensees by companies who have a specific license from'the Commission or an Agreement State authorizing such distribution. This .
document combines and supersedes the guidance previously found in Information Notices and Policy and Guidance documents listed in Table A-1 (page 59) in this NUREG.
This document also provides assistance to applicants and licensees in preparing license
- applications. It also describes the methods acceptable to NRC license reviewers in implementing
- the regulations and the techniques used by the reviewers in evaluating the applications to j determine if the proposed general distribution activity is acceptable for licensing purposer. This
~ document was not intended for providing guidance to applicants requesting a specific license for possession and use of radioactive materials. Appendix K to this NUREG is specifically directed at the general licensee and could be sent to the licensee's customer (the general licensee) to provide the general licensee with a concise listing of the regulatory requirements that apply to
_ general licensed devices. It is not intended, however, to take the place of the information (s
- requirements of 10 CFR 32.51a (a) and (b).-
The guidance contained herein does incorporate new and proposed regulatory requirements in 10 CFR 31 and 32.
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iii Draft NUREG - 1556, Vol.16
o . 3 i l l i l k I
CONTENTS ,
ABSTRACT...............................................................................iii FOREWORD..............................................................................ix ACKNO WLE DG M ENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x i A B BR EVI ATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii i P URPOS E O F D RAIT REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1 l 2 AG RE EM ENT STATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2- 1 3 MANAG EMENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 4 A PPLICA BLE REG ULATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 5 G EN E RA L LICENS E DISTRI B UTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 5.1 GENERAL... .. ..... ........... ......... ..... ..... .... . ... . . ,, 5-1 5.2 LICENSING AND SEALED SOURCE DEVICE REGISTRATION . . . . . . .. . . . ... 5-2 5.3 TYPES OF GENERALLY LICENSED DEVICES . . .. .. ... ... . ... ..... . .. 5-3 l l
5.4 PROPRIETARY INFORMATION . . .......... ... ......... .. . .... . .. . . ... 5-7 !
5.5 FOREIGN VENDORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ .. .. . 5-8 6 H O W TO FI L E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6- 1 l 6.1 PAPER A PPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... .... . . . 61 I 1
6.2 ELECTRONIC A PPLICATION . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 1 6.3 WH ERE TO FILE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ ............ ... 6-2 7 A PPLICATION AN D ANNUAL FE ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 l I
8 CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.1 ITEM 1 : LICENSE ACTION TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 !
8.2 . ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.2.1 TIMELY NOTIFICATION OF TRANSFER CONTROL .. .. ................ 8-2 1
8.2.2 NOTIFICATION OF BANKRUPTCY PROCEEDINGS . . . . . . . . . . . . . . . ... 8-3 i 8.3 -' ITEM 3: ADDRESS (ES) FROM WHICH LICENSED MATERIAL WILL BE DISTRIBUTED . . 8-4 8.4 - ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION ....... .......... 8-4 8.5 ITEM 5: RADIOACTIVE MATERIAL AND PURPOSES FORWHICH LICENSED MATERIAL WILL BE USED . . . . . . . . . . . . . . . . . . . .... . .... . ..... ............. .... 8-5 8.6 ITEMS 7,8.9 & 11: NOT APPLICABLE . .. . ....... ...... ...................... 8-6 8.7 ITEM 10: RADIATION SAFETY PROGRAM (REQUIREMENTS FOR A GENERAL i DISTRIBUTION LICENSE) . . . . ......... .................. .. . . . . .......... 8-6 l 8.7.1 10 CFR 32.51: REQUIREMENTS FOR INITIAL TRANSFER OF DEVICES FOR USE UNDER 10 CFR 31.5 . . . . . . . . . . . . . . . . . . . . . . . .... . ........... 8-6 8.7.2 10 CFR 32.53: REQUIREMENTS FOR INITIAL TRANSFER OF LUMINOUS SAFE'IY DEVICES FOR USE IN AIRCRAFT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 8.7.3 10 CFR 32.57: REQUIREMENTS FOR INITIAL TRANSFER OF CALIBRATION I OR REFERENCE SOURCES CONTAINING AMER]CIUM.241 . . . . . . . . . . . . . . . 8-9 l 8.7.4 10 CFR 32.61: REQUIREMENTS FOR INITIAL TRANSFER OF ICE DETECTION i DEVICES CONTAINING STRONTIUM.90 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8- 10 8.7.5 10 CFR 32.71: REQUIREMENTS FOR INITIAL TRANSFER IN VITRO KITS UNDER 10 CFR 31.11 . . . . . . . . . . . ... .......... .......................8-10 8.8 ITEM 12: FEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. .. .... ... 8-12 f
v Draft NUREG - 1556. Vol.16 l
i CONTENTS 8.9 . ITEM 13: CERTIFICATION OF APPLICATION . . . . . . . . . . . . . . .. . ...... 8-12 9 DEFICIENCY IN TiiE APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 t o ISSU ANCE OF A LICENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 11 ' AMENDMENTS AND RENEWALS TO A LICENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Il-1 12 APPLICATIONS FOR EXEMPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1 13 TERMINATION OF ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 APPENDICES A. List of Documents Considered in Development of this Draft NUREG .. .......... . . . . ....A1 B. United States Nuclear Regulatory Commission Form 313 . . . . . ................ . .... .. B-1 C. Sample (SSD) Registration Certificates for Generally Licensed Products . . . . .. . . . . . . . . . . . . . . . . . C- 1 D. 10 CFR 2.790: Withholding Letter . . . .. . . . . . . . . . . . ....... ... ... .................D-1 E. Information Needed for Transfer of Control Application (Excerpteil from Information Notice 89-25) . . . E-1 F. Review Checklist for General Distribution License Application (32.51) . . . . . . . . . . . . . . . . . . . . .... F-1 G. Review Checklist for General Distribution License Application (32.53) . . . . . . . . . . . . . . . . . . . . . . . . . G 1 H. Review Checklist for General Distribution License Application (32.57) . . . . . . . . . . . . . . . . . . . . . . . . . H- 1
- 1. Review Checklist for General Distribution License Application (32.61) . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 J. Review Checklist for General Distribution License Application (32.71) . . . . . . . . . . . . . . . . . . . . . . J-l K. Guidance for General Licensees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....................K1 L General License Registration FormFORM FOR CERTAIN DEVICES LISTED IN 10 CFR 31.5 . . . . . . L-1 M. Materials License - Form 374 Format . . . . . . ................ ..... ... ..................M-1 N. Deemed Timely Letter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N- 1 O. Form NRC-483 " Registration Certificate - In Vitro Testing with Byproduct Material Under General License"..........................................................................O-1 P. Form XXX-Transfers ofIndustrial Devices Repott . . . . . . . . . . . . . . . . . . . ... ..................... P-1 FIGURES Figure 2.1 U.S. Map...................................................... ... ..... 2-1 Figure 5.1 Gas Chromatograph Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Figure 5.2 Fixed Gauging Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ... ........... ...... 5-4 Figure 5.3 Static Eliminators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Figure 5.4 Lum inous Exit Sign . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Figure 5.5 Calibration Standards . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Figure 5.6 In Vitro Kit . . . . . . . . . . . . . . . . . . . . . ................... ............. .. ........ 5-7 Figure 8.1 G auge Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...... .... .. .. ..... .. 8-9 Figure 8.2 Package Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..........B-11 Draft NUREG - 1556, Vol 16 - vi 1
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CONTENTS Figure K.1 Fixed Gau ges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . K- 1
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Figure K.2 - U .S . Map' . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . K-7 TABLES
- Table 2.1 Who Regulates the Activity? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Table A.) List of Documents Considered in the Preparation of this Report . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 1
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- FOREWORD -
The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in L NUREG-1539," Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996.-- A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG series of reports. Below is a list of volumes currently included in the NUREG-1556 series.
- Vol ~ Volume Title Status,
- No.
1 Program-Specific Guidance About Portable Gauge Licenses Final Report
- 2. Program-Specific Guidance About Industrial Radiography Licenses Final Report 3 Applications' for Scaled Source and Device Evaluation and Final Report Registration 4 Program-Specific Guidance About Fixed Gauge Licenses Final Report 5 Program-Specific Guidance About Self-Shielded Irradiator Final Report W enses 6 Program-Specific Guidance About 10 CFR Part 36 Irradiator Final Report Licenses 7 Program-Specific Guidance About Academic, Research and Draft for Comment Development, and Other Licenses of Limited Scope .
8 Program-Specific Guidance About Exempt Distribution Licenses Final Report
.9 Program-Specific Guidance About Medical Use Licenses Draft for Comment 10- Program-Specific Guidance About Master Material Licenses Draft for Comment 11 Program-Specific Guidance About Licenses of Broad Scope Draft for Comment ,
13- Program-Specific Guidance About Commercial Radiopharmacy Draft for Comment Licenses
- 14. Program-Specific Guidance About Well Logging, Tracer, and Field Draft for Comment Flood Study Licenses 15 Guidance About Changes of Control and About Bankruptcy Draft for Comment Involving Byproduct, Source, or Special Nuclear Material Licenses The current document, draft NUREG-1556, Vol.16, " Consolidated Guidance about Materials
- Licensesi Program-Specific Guidance about Licenses Authorizing Distribution to General Licenses," dated March 1999, is the sixteenth program-specific guidance developed for the new ix Draft NUREG - 1556, Vol.16
- 1 1
m FOREWORD i
process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC l
personnel.
.A team composed ofNRC staff from Headquarters and Regional Offices drafted this document,
. drawing on their collective experience in radiation safety in general and knowledge of general distribution of radioactive products. A representative of NRC's Office of the General Counsel provided a legal perspective.
Draft NUREG-1556, Vol.16," Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Licenses Authorizing Distribution to General Licenses," dated March 1999, represents a step in the transition from the current paper-based process to the new electronic process.- NRC is requesting comments such as whether a risk-informed, performance-based approach to licensing is valid as well as comments on the information provided. Please submit comments within 90 days of the draft report's publication. Comments received after that time will be considered if practicable. This document is available on the Internet at the following address:
<http 1/www.nrc. gov /NRC/NUREGS/SR1556/V16/index.html>.
This draft report is strictly for public comment and is not intended for use in preparing or reviewing applications for general distribution licenses until it is published in final form. It is being distributed for comment to encourage public participation in its development.
Address comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
. Hand 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 Inte net by addressing electronic mail to diml@nrc. gov.
Draft NUREG-1556, Vol.16, " Consolidated Guidance about Materials Licenses:
Program-Specific Guidance about Licenses Authorizing Distribution to General Licensees,"
dated March 1999, is not a substitute for NRC regulations, and compliance is not required. The
. approaches and methods described in this report are provided for public comment only.
Donald A. Cool, Director
. Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
< Draft NUREG -'1556, Vol 16 x
r l ACKNOWLEDGMENTS 1
1 The writing team thanks the individuals listed below for assisting in the development and review of the draft report. All participants provided valuable insights, observations, and ecommendations.
The team also thanks Kay Avery, Judy Boykin, Randy Glantz, D. W. Benedict Llewellyn, Steven W. Schawaroch, Agi Seaton, Gina G. Thompson, and Nora Younger of Computer )
l Sciences Corporation.
l The Participants l
l Baggett, Steven L.
Burgess, Michele L.
Cain, Charles L.
Camper, Larry W.
Caniano, Roy J.
Collins, Doug M.
Combs, Frederick C.
Cool, Donald A.
Johansen, Jenny M.
Lubinski, John W.
Kinneman, John D.
McCausland, Jayne M.
Mattsen, Catherine R.
Merchant, Sally L.
Minnick, Sheri A.
Pangburn, George C. l
. Parker, Bryan A.
l Roe, Mary Louise Schwartz, Maria E.
Treby, Stuart A, Wiedeman, Darrel G.
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L ? ABBREVIATIONS
- ALARA - As Low as Is Reasonably Achievable
, . ANSI 'American National Standards Institute BPR- Business Process Redesign .
Bq Becquerel
'CFR- ' Code of Federal Regulations Ci Curie DOE . United States Department of Energy DOT-- United States Department of Transportation GBq . gigabecquerel-GL general license -
GPO- Government Printing Office' l .IL Interpretive Letter IMNS' - Division ofIndustrial, Medical, and Nuclear Safety IN' Information Notice
.kBq kilobecquerel .
mci millicurie
-MSB Materials Safety Branch NA- not applicable NMSS Office of Nuclear Material Safety and Safeguards -
NRC Nuclear Regulatory Commission
.OCFO Office of the Chief Financial Officer OCR optical character reader OGC L Office of the General Counsel OMB Office ofManagement and Budget QA quality assurance QC- . quality control '
.R- . roentgen RG. Regulatory Guide RI- responsible individual
- RSO- radiation safety officer
! SI International System of Units (abbreviated SI from the French Le Systeme Intemationale d' Unites)
SSD' , scaled source and device std . standarti
~ TAR tecimical assistance request USC ' United States Code Ci , microcurie:
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1 PURPOSE OF DRAFT REPORT This document is strictly for public comment and is not for use in preparing or reviewing applications for licenses authorizing distribution to general licensees until this document is published in final form.
This report provides guidance to an applicant in preparing an application to distribute generally licensed products or devices as well as NRC criteria for evaluating a general distribution license application. This report also provides guidance to general licensees covered in 10 CFR 31.5 on the use, possession, and registration requirements for general licensees.
General distribution licenses authorize the distribution (initial transfer) of byproduct material to persons generally licensed by 10 CFR 31.3,31.5,31.7,31.8,31.10 and 31.11.
This draft report identifies the information needed to complete NRC Form 313 (Appendix B),
" Application for Material License," for the use of byproduct material contained in devices or products distributed to general licensees. The information collection requirements in 10 CFR Parts 30 and 32 and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, 3150-0001, and 3150-0120, respectively.
The format within this document for each item of technical information is as follows:
- Regulations - references the regulations applicable to the item.
Criteria - outlines the criteria NRC uses to judge the adequacy of the applicant's response. :
Discussion - provides additional information on the topic sufficient to meet the needs of l most readers.
Response from Applicant - provides suggested response (s), offers the option of an attemative reply, or indicates that no response is needed on that topic during the licensing process.
Notes and references are self-explanatory and may not be found for each item on NRC Form 313.
! l-1 Draft NUREG - 1556, Vol.16
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- i 2 AGREEMENT STATES Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to licelse and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant, other than a Federal Agency, who wishes to possess or use byproduct, source, or special nuclear material in one of these Agreement States needs to contact the responsible officials in that State for guidance on l l
preparing an application. A current list of Agreement States, including the names, addresses, and telephone numbers of responsible officials, may be obtained upon request from NRC's Regional l Offices. This information can also be found on the NRC Office of State Programs' web site at
<http://www.hstd.oml. gov /nrc/asframe.htm>.
Locations of NRC Offices and Agreement States !
Region IV Region 111 1 MN NH
', MA Region I
~
So MI V j OR -) 1D wy l '
- IA '
- PA O RI
'NE' IN OH IL NJ CT !
NV s MO D C' tir L CO? '
WV DE I CA N~TN /
- ~
LA . e AK M I
VT FL C
- Reglon 11 Region ll PR l 61 Forsyth Street, SW, Suite 23T85 l
Atlanta, GA 30303 !
9 RegionalOffice Q Headquarters 404-562-4400, 1-800-577-8510 C 30 Agreement States Region til !
(approx.15,800 specife licensees) Headquarters 801 Warrenville Road O 20 Non-Agreernent States Washington, D.C. 2055WO1 Lisle, IL 60532-4351 OW7000,1-800 36&5642 !
(approx. 6,000 specific licensees) 630-829-9500, 1-800 522-3025 j Note: Alaska and Hawaii are included in Region 1 Region IV f Region IV, Puerto Rios end Virgin Islands 475 Allendale Road 611 Ryan Plaza Drive, Suite 400 in Region it, The Distnct of Columbia in l King of Prussia, PA 19406-1415 Ariington, TX 76011-8054 il Region i 610-337-5000,1-800-432-1156 817-860-8100, 1-800-952-9677 BCc001b ppt f
i 033199 q Figure 2.1 U.S. Map. Location ofNRC Ofices andAgreement States.
Table 2.1 provides a quick way to determine which Agency has regulatory authority over the '
possession and use of byproduct, source, or special nuclear material.
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l AGREEMENT STATES Table 2.1 Who Regulates the Activity?
Applicant and Proposed Location of Work Regulatory Agency Federal Agency regardless oflocation (except that Department of Energy NRC
[ DOE] and, under most circtunstances, its prime contractors are exempt from licensing [10 CFR 30.12])
Non-Federal entity in non-Agreement State, U.S. 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-controlled site not Agreement State subject to exclusive Federaljurisdiction Any entity in any State requesting authorization to distribute devices for NRC use under 10 CFR 31.3 ,
Non-Federal entity in Agreement State at Federally-controlled site subject NRC to exclusive Federaljurisdiction Draft NUREG - 1556, Vol.16 2-2
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1 3- MANAGEMENT RESPONSIBILITY The NRC recognizes that effective radiation safety program management is vital to achieving safe and compliant operations. NRC believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely. NRC also believes that effective management will result in increased safety and compliance.
" Management" refers to the processes for conducting and controlling radiation safety programs ;
and to the individuals who are responsible for those processes and who have authority to l provide necessary resources to achieve regulater compliance.
To ensure adequate management involvement, a management representative must sign the submitted application acknowledging management's commitments and responsibility for the ,
following: 1
- Completeness and accuracy of all information provided to NRC (10 CFR 30.9);
- Knowledge about the contents of the license and application;
. Compliance with current NRC and Department of Transportation (DOT) regulations;
- Prohibition against discrimination of employees engaged in protected activities (10 CFR 30.7);
- Commitment to provide information to employees regarding the employee protection and deliberate misconduct provisions in 10 CFR 30.7 and 10 CFR 30.10, respectively; Obtaining NRC's prior written consent before transferring control of the license; and
. Notifying appropriate NRC Regional Administrator in writing,immediately following filing of a petition for voluntary or involuntary bankruptcy;
. Ensure that all general licensed devices are constructed and distributed in accordance with NRC requirements.
For information on NRC inspection, investigation, enforcement, and other compliance programs, see the cunent version of" General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600. NUREG-1600 is available electronically at <http://www.nrc. gov /OE>.
For hard copies of NUREG-1600, see the Availability Notice (on the inside front cover of this report).
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4 APPLICABLE REGULATIONS The regulations applicable to persons who possess byproduct material in generally licensed products are located in 10 CFR Part 31. Part 32," Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material" outlines, in part, the information 3 required to initially transfer for sale or distribute products containing byproduct material. The following is a list of the regulations for general licensees in Part 31 and the corresponding requirements for distributors of generally licensed products in Part 32.
$ 31.3 Certain devices and cauipment Distribution of general licensed devices authorized under 10 CFR 31.3 can be issued only b', the l NRC. There are no corresponding regulations in 10 CFR Part 32. Each device is evaluated on a I case-by-case basis.
6 31.5 Certain measurine, eaurine. or controlline devices j Q 32.51 Byproduct material contained in devices for use under 31.5; requirements for ,
license to manufacture, or initially transfer ;
Q 32.51a Conditions oflicenses Q 32.52 Material transfer reports and records Q 31.7 Luminous safety devices for use in aircraft f 32.53 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair, or initially transfer
{ 32.54 Labeling of devices
{ 32.56 Material transfer reports 1314 Americium-241 in the form of calibration or reference sources Q 32.57 Calibration or reference sources containing americium-241; Requirements for license to manufacture or initially transfer 32.58 Labeling of devices 6 31.10 General license for strontium-90 in ice detection devices
{ 32.61 Ice detection devices containing strontium-90; requirements for license to f
! manufacture or initially transfer 4-1 Draft NUREG - 1556, Vol.16 L
APPLICABLE REGULATIONS 1
'6 31.11 General license for use of hvoroduct material for certain in vitro clinical or laboratory testine l
{ 32.71 Manufacture and distribution of byproduct material for certain in vitro clinical I or laboratory testing under general license i
Additional regulations applicable to holders of a general license and distributors of generally l licensed products are found in the following 10 CFR Parts:
10 CFR Part 19," Notices, Instmetions, and Reports to Workers: Inspection and Investigations"
. 10 CFR Part 20," Standards for Protection Against Radiation"
. 10 CFR Part 21, " Reporting of Defects and Noncompliance"
- 10 CFR Part 30," Rules of General Applicability to Doniestic Licensing of Byproduct Material"
. . 10 CFR Part 71, " Packaging and Transportation of Radioactive Material"
= 10 CFR Part i10, " Export and Import of Nuclear Equipment and Material"
. 10 CFR Part 170," Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended"
= 10 CFR Part 171, " Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by NRC" It is the applicant's or licensee's responsibility to have up-to-date copies of applicable regulations, read them, and abide by each applicable regulation.
To request copies of the above documents, call GPO's order desk in Washington, DC, at (202) 512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, Pans 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact the GPO electronically at
<http://www.gpo. gov >. Request single copies of the above documents from NRC's Regional Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC publishes amendments to its regulations in the Federal Register.
I Draft NUREG - 1556, Vol.16 4-2
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1 5 GENERAL LICENSE DISTRIBUTION 5.1 GENERAL I On February.12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license for the use of byproduct material contained in certain measuring, gauging, or controlling devices. Under current regulations (10 CFR 31.5), certain persons may receive and use a device containing byproduct material under this general license if the device has been manufactured and distributed according to the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license authorizing distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements. The general licensee must comply with the requirements for labeling, instructions for use, and proper storage or disposition of the device. {'
A generally licensed device usually consists of radioactive material, contained in a sealed source, ,
within a shielded device. The device is designed with inherent radiation safety features so that it l can be used by persons with no radiation training or experience. Thus, the general license is I meant to simplify the licensing process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.
The distributor of the general licensed product / device is required to ensure to the Commissionor the Agreement State that all products are distributed in accordance with the specifications provided in its license application. These specific licenses are issued by the Commission or Agreement State and are referred to as " general distribution" licenses. See Appendix M for example of a general distribution license.
General distribution licenses only authorize the distribution of products and device (s) to general l licensees and do not authorize possession or use of radioactive material. Therefore, applicants a for general distribution licenses will need to file a separate application for a specific license authorizing possession and use of byproduct material, with the NRC Regional Office or
- Agreement State for the State in which the material will be possessed and/or used. However, the i determination of where to file the general distribution license application should be made based l J
on the location from which the applicant wishes to distribute, not necessarily where the applicant possesses and/or uses the byproduct material (i.e., where the product is manufactured). The four ,
Regions and the Regional Office addresses are provided on NRC Form 3 or in 10 CFR Part 20, Appendix D or Section 2 of this document (Figure 2.1). A license authorizing distribution to general licensees can not be issued until the applicant (1) obtains a registration certificate for the device (if applicable) and (2) obtains a possession and use license. To expedite the licensing process, the applicant should apply for the possession license and registration certificate l concurrently, then apply fer authorization to distribute.
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i 5-1 Draft NUREG - 1556, Vol.16 ;
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GENERAL LICENSE DISTRIBUTION 5.2 LICENSING AND SEALED SOURCE DEVICE REGISTRATION Applicants of a general distribution license are required to provide specific information about the sources and products as outlined in { 32.51,32.53,32.57,32.61, and 32.71 concerning the radionuclides and activities, containment and construction, labeling, quality control and assurance programs, etc. NRC will evaluate the information submitted in the application to ensure it meets all applicable standards and regulations and will contact the applicant, if necessary, to obtain additional clarification or information.
A sealed source and device (SSD) safety evaluation will be performed on the sealed sources and devices the applicant proposes to distribute to general licensees. Information about the review and approval process for Sealed Sources and Devices is contained in NUREG-1556, Vol. 3.
Upon completion of the SSD evaluation, a registration certificate will be issued. The registration certificate must be complete and available before the licensing reviewer may issue the license.
An SSD evaluation and registration certificate is required for all devices authorized in 10 CFR 31.3,31.5,31.7, and 31.10. An SSD evaluation is not required for devices / products authorized in 10 CFR 31.8 and 31.11.
After the issuance of a license, licensees must conduct their programs for the distribution of generally licensed products / devices in accordance with the following:
. Statements, representations, and procedures contained in their application, and other .
l correspondence with NRC
= Terms and conditions of the license
. Device registration,if applicable
. Applicable NRC regulations.
Section 30.9 of 10 CFR Part 30," Rules of General Applicability to Domestic Licensing of Byproduct Material," requires that the information provided in the application be complete and accurate in all material respects. Information is considered to be material ifit is likely to change or affect an Agency decision on issuing the license; therefore, information should be clear, specific, and accurate. Section 30.10,10 CFR Part 30," Deliberate misconduct," states that those providing information concerning a licensee's activities may not deliberately engage in misconduct or provide incomplete or inaccurate information to the NRC.
It is important that applicants and licensees understand that the information provided in an application and approved in the license is considered a limitation by NRC on the licensee to engage only in those activities and products as described in the application or license. NRC should be notified of any changes or additions to the information submitted in the application.
While some changes may not result in an amendment to the license, licensees should not assume Draft NUREG - 1556, Vol.16 5-2
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- GENERAL LICENSE DISTRIBUTION that an amendment is not needed or that an amendment request has been granted until they receive a written confirmation in the form of a letter or license amendment.
l 5.3 TYPES OF GENERALLY LICENSED DEVICES General distribution licenses are based on the types of products / device (s) to be distributed according to the six categories ofproducts/ device (s) found in 10 CFR Part 31. The following provides the applicable regulation and some examples of products / device (s) that may be distributed under a general distribution license and possessed by a General Licensee:
6 31.3 and 31.5 Certain measurine, caueine or controlline devices
. Byproduct material contained in devices designed and manufactured 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.
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i Figure 5.1 Gas Chromatograph Units. Certain gas chromatograph units (detector cells) used for analysis ofchemical composition can bepossessed under a generallicense (10 CFR 31.5).
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5-3 Draft NUREG - 1556, Vol.16 )
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s e GENERAL LICENSE DISTRIBUTION Transmission Gauge Insertion Gauge C
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, Fill Level Gauge Density Gauge n.sa .cssamg Figure 5.2 Fixed Gauging Devices. Certain nuclear gauges can bepossessed under a general license (10 CFR 31.5).
Draft NUREG - 1556, Vol.16 5-4
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'1 0 j could be identified as containing radioactive material, thereby reducing the likelihood of l incidents resulting in unnecessary exposures to the public and contamination of property.
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.C. ost impacts:
Assumptions:
Distributors:
Total NRC licensee cost per year: I Number of devices with separable source housings manufactured per year (5% of 9351 devices): 468 Price of additionallabel: $4 Number of devices requiring registration 305 !
manufactured per year:
Price of permanent label: $13 ;
Total NRC licensee cost per year: $5,837 '
Estimated Agreement State licensee cost per year:
Number of devices with separable source housings manufactured per year 1300 !
Price of additionallabel: $4 Number of devices requiring registration l manufactured per year: 800 Price of permanent label: $13 Estimated Agreement State licensee cost per year: $15,600 i
Total cost per year: $21,437 I This provision would not be expected to result in a significant impact to the NRC licensing staff for additional reviews of labels.
No significant effect on inspection and enforcement is anticipated.
E. Information provided to general licensees: Conditions of licenses ($ 32.51a(a) and (b))
The proposed rule would revise @ 32.51a(a) and (b) requirements pertaining to information distributors would be required to provide to the general licensee. They are now required to provide generallicensees with a copy of f 31.5 at the time of transfer of the device. The proposed rule would require that 9 31.5 be provided prior to transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of
! services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred. The disposal options would include the cost of disposing of the device at the end of its useful life to the extent that the cost information is available to the specific licensee distributor at the time of the sale of the device. This is to provide general licensees with information needed concerning the applicable requirements as well as some idea of the additional costs for disposal of the device before making a decision to buy a device. ;
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, t Cost Impacts:
Assumptions:
Distributers (NRC and Aareement State):
Number of NRC general licensees who are shipped generally licensed devices per year: 4,277 Time spent to provide additionalinformation: 0.03 hr Technical staff hourly rate $50/hr Total licensee cost per year for distribution to NRC generallicensees: $6,415 Estimated number of Agreement State generallicensees shipped generally licensed devices per year: 12,000 Time spent to provide additional information: 0.03 hr ,
Technical staff hourly rate $50/hr ]
Total licensee cost per year for distribution to l l Agreement State generallicensees: $18,000 Totallicensee cost: $24,415 No significant effect on inspection and enforcement is anticipated. i 4.3 Other Clarifying and Conforming Amendments A. Types of licenses ($ 30.31) i The proposed rule would add a clarifying amendment in 30.31.
l Cost imoacts:
None B. Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of 1954, as amended (Part 170)
The proposed rule would make minor conforming amendments to 69170.2 and 170.3.
C. Annual Fees for reactor operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality i assurance program approvals and government agencies licensed by NRC (Part 171)
The proposed rule would also make minor conforming amendments to f@ 171.5 and 171.16.
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4.4 Summary of Estimated Annual Costs of Proposed Rule Table 4-1 presents a summary of the estimated costs of the revisions to Parts 30,31,32,170, and 171. For each regulatory change described above, Table 4-1 lists the costs estimated for that section.
Table 4-1 Summary of the Proposed Rule's Annual Cost Effects Subpart Section Licensee Costs NRC Costs 4.1 A 31.5 (c)(13) 0 0 4.1 B 31.5 (c)(12) 0 0 4.1 C 31.5 (c)(15) variable, unquantified 0 4.1 D 31.5 (c)(8) 0 3,500 4.1 E 31.5 (c)(14) 500 700 4.1 F 31.5 (c)(5) 2,800 980 4.1 G 31.5(c)(9)(i) 0 0 4.1 H 31.5(b) 0 0 4.11 30.34(h) 0 0 ,
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4.1 J 170.31 2,220,000 100,000 1 4.2 A 32.52 (a) and (b) 12,460 2,492 4.2 B 32.52 (c) 0 0 4.2 C . 32.51a (d) 0 0 4.2 D 32.51 (a)(4) and (5) and 21,437 0 i 32.51a (c) 4.2 E 32.51a (a) and (b) 24,415 0 4.3 A 30.31 0 0 4.3 B 170 0 0 4.3 C 171 0 0 4.5 Annual Costs to Agreement States of Compatible Regulations Assuming that the Agreement States have jurisdiction over roughly twice as many devices as the NRC in total, and assuming the same average cost / licensee, approximate costs to Agreement States for carrying out a comparable oversight program would be estimated as 19
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$83,000/ year after the first year or two. The first year costs would be higher, roughly $190,000.
However, the smaller number of general licensees and specifically licensed distributors in
- individual States relative to the total number of NRC licensees may result in higher average costs / licensee. This cost is the administrative cost of exercising a similar level of control as the registration requirement initiated in Rule 1, which would now be a Compatibility Category C and for the additional requirements that would be placed on distributors, which would be Compatibility Category B. This does not include the cost of collection of fees, as this is .
' Compatibility Category D. Also, the registration process or other oversight program will likely uncover noncompliance with existing rules leading to a significant cost of followup, especially in the early years of implementation; this is also not included in this estimate as it is not a direct cost of compatibility with this rule, rather an enforcement of existing rules. The actual cost of achieving Compatibility level C for general licensees will depend on the approach taken by the various States and how much change this requires from existing requirements. In some cases, Agreement States have already instituted a registration system or other enhanced oversight program. In these cases, little or no additional action may be needed.
4.6 i Development and implementation Costs NRC development costs are the costs of preparation of a regulation prior to its promulgation and implementation. Such costs may include expenditures for research in support of this reg'ulatory action, publishing notices of rulemaking, holding public meetings, responding to public comments, and issuing a final rule. NRC implementation cost are those " front-end" costs necessary to effectuate the action; they may arise from the necessity of developing procedures and guidance to assist licensees in complying with the final action.: The Working Group's recommendations, published as NUREG-1551 in October of 1996, which is the research in support of this regulatory action, has already been performed and is therefore outside the scope of this analysis.- Developmental and implementation costs within the scope of this analysis are the costs of proceeding with a rulemaking, as well as efforts on guidance development associated with this rule. These are mainly costs of the effort of NRC professional staff members in the Office of Nuclear Materials Safety and Safeguards expended in i developing the rule.
The action's preparation cost to the NRC'is estimated to require a total of 4 professional staff-years. The estimated cost of one NRC professional staff member is $126,000/ staff-yr.
The component of NRC's development cost due to staff effort, then, would be $504,000.
Registration will require a more efficient computer data base. 'A computerized directory has been previously used by the Commission. However, it is outdated and will require improvement or replacement; this would be the case if it is to be adequate for carrying out the Commission's mission in the area of general ~ licenses. This computer system upgrade cost was addressed in the previous proposed rule, which is to be used as a basis for initiating a registration, and, therefore, no additional cost is provided in this analysis.
Additional costs will be incurred by the Agreement States for development and implementation of compatible regulations, including the change to Compatibility Category C for all of 31.5. !
The costs will vary significantly by State because of differences in intemal procedures for I developing regulations and in the state of existing regulations in each State, some States having already instituted an enhanced oversight program, in some cases, specifically a 20
.s' a l' registration program. . Even in these cases, some rule change will be required to meet compatibility Category B for requirements for distributors. As these need to be essentially l
word-for-word compatibility, the process should be relatively simple for this part. If we assume L an average of 1 FTE at $105,000/FTE for 30 States, the cost would be $3,150,000. In addition, I the NRC/ Agreement State Working Group. estimated that the cost of each State setting up a
- database for use in implementing such a program would be $20,000. Although some progress i
has been made by some States, we assume the same amount for all 30 States for a total of
$600,000. Thus, total front end costs to Agreement States would be in the area of $3,750,000.
, Revision of distributors' manufacturing process to include additional labels would result in small 1-incremental costs (i.e. <$1,000).
5 BENEFITS OF PROPOSED RULE 5.1 Summary of Benefits of Proposed Alternative The revisions are intended to better ensure understanding of and compliance with the general
. license requirements, and thereby reduce the likelihood of incidents resulting in unnecessary j exposures to the public and contamination ci property. These revisions will better enable the j NRC to track the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program. NRC needs to keep track of the generallicensees so that they can be contacted or inspected. Further, the revisions would improve the likelihood that labels on devices will be retained under most circumstances so that devices can be identified and appropriate actions can be taken. A number of the proposed provisions work 1 together to achieve these benefits. Thus, the benefits of these provisions cannot be accounted 1 separately. The basic rationale for each provision is discussed in Section 4; the overall benefits are discussed below.
The primary benefits of this proposed rule can be categorized into economic benefits and exposure aversion benefits. In addition, there are less tangible benefits to improving accountability for generally iicensed devices. Many incidents involving generally licensed devices occur in the public domain. As a' result, incidents to be averted by this rule have a significant impact on the public's perception of risks associated with the use of radioactive material. This, in tum, can affect the credibility of NRC in other areas. Therefore, this rulemaking could contribute to the alleviation of inappropriate public fear and improvement of NRC credibility in the future.
All of these benefits are very difficult to quantify. Although ranges of potential exposures have been calculated and ranges of costs from individual incidents have been recorded, the working group concluded that none of the studies conducted are adequate to quantify an overall net cost of improperly disposed or lost devices. An admittedly uncertain estimate was made of the current economic costs and exposures resulting from improper disposition of both specifically and generally licensed devices meeting the proposed criteria for increased oversight. The
~ degree of effectiveness of a particular process is also uncertain and would depend on the level of effort used in enforcement of the provision.
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. 4 l The estimate of. economic costs made by the working group and adjusted here for the number
, ' of devices covered by this proposed action is based on experience (as reported by the steel industry). -
Uncertainty in these estimates comes from a number of factors including:
. . The number of incidents of meltings reported is small overall. Thus, there is considerable statistical uncertainty in how representative the costs are of future costs averted.
. The likelihood of loss may be different for specifically and generally licensed devices and for different categories of devices. The experience cannot be
. separated because it usually cannot be determined whether a generally or specifically licensed device was involved once a melting has occurred.
.' The cost of a cleanup depends on the type of steel mill. Experience reported did
. not include incidents at large integrated steel mills and the resultant costs of such an incident are expected to be much greater than those experienced to date, as much as $100 million for a single incident.
. The likelihood of meltings depends on the level of effort on the part of metal manufacturers and recyclers in monitoring for radioactive sources in scrap, which has generally increased over time, particularly at larger mills.
5.2 Summary of Radiation Exposure Averted Benefit This rule should avert radiation exposure to the public. Although it is reasonable to assume that a member of the public would not deliberately expose himself or herself or someone else to radiation, in some cases, these individuals ~ might not understand that a gamma gauge is a
.' potential source of radiation. When a gamma gauge is distributed to a general licensee, the gauge must bear durable, legible labels which include a caution that the gauge contains .
radioactive material.' The general license in 6 31.5 requires that the general licensee maintain ;
those labels. In the absence of such maintenance, however, the cautionary language can j become corroded and unreadable or painted over. An individual who finds the gauge without _!
this labeling in an uncontrolled situation would have no reason to suspect that the gauge contains radioactive material.
If a generally licensed gauge were improperly transferred or disposed of such that it became available to a member of the general public, provided the radioactive material sealed source remained in the gauge and the shutter mechanism remained closed, no significan_t radiation exposure harm could result. Moreover, the gauge may be too heavy for anyone to casually relocate so as to cause long-term exposure. In addition, temporary exposure to an intact gauge
' should not cause a significant radiation dose. Also, the intact gauge would normally include a waming label with a radiation symbol and cautionary words.
If a gauge with a significant source of activity were to end up in the public domain, the labeling were to be destroyed, and a person somehow exposed the source, a significant exposure could result.L Radiation exposure due to improper control could conceivably result in doses of a few rem to doses that are life threatening. However, the likelihood of situations which could result in
, the highest doses is extremely small.. No incidents to date in the U. S. have resulted in the upper range of these potential doses.
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Based on a June 1994 PNL report, " Peer Review of improper Transfer / Disposal Scenarios for Generally Licensed Devices," the working group (WG) estimated the average dose received q
. from incidents of lost devices involving cesium-137 (the most common nuclide involved in
)
incidents historically) could be 7 rem (70 mSv) and the maximum dose that might be received l
could be somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges i f containing 20 mci or greater of cesium-137. The analysis was based on the average activity of 883 mci of cesium-137 within this category using data from the General License Data Base on devices registered in the Sealed Source Device Registry (SSDR) during the period 1987-1992.
The activities listed in the SSDR are the maximum allowed in a model and thus overestimate 3 the average for the devices actually distributed. Gamma gauges were chosen for the example l analysis as representative of relatively high risk sources amongst generally licensed devices. !
These were very rough estimates. The data has known errors and the average activity per I device being distributed has declined.
5.3 Summary of Economic Benefits There is a cost savings to industries which might inadvertently come into possession of an t ~ improperly disposed device. The most significant of these would be the avoidance of a melting of a source and resulting contamination of a steel mill and.its products and wastes.
Based on the known incidents in the period 1983-1995 involving the nuclides for which registration would be required, the cost of decontamination and clean-up of these incidents (using the average clean-up costs) is about $12 million per year. This cost can be considered as a societal cost which may be mitigated or possibly averted in the future if the rule is .
implemented. The regulatory analysis for the previous proposed rule (Rule 1) estimated that it would cover 20 percent of the devices contributing to the melting experience to date (since that rule addressed only devices in NRC-regulated States and some of the melted devices may have been specifically licensed) and might reduce the rate of incidence involving those devices by half, and estimated that the average annual cleanup cost of $12 M would be reduced by about $1.2 M per year.
This rule would require Agreement State Compatibility Category C for the regulations governing general licensees, so that generally licensed devices in Agreement States would be similarly controlled. Based on the estimates of the WG, this would involve approximately half of the devices considered by the WG as likely contributors to smelting incidents and as presenting a risk of significant exposure to the public. If we again estimate that the increased oversight of these devices reduces smelting incidents by one half amongst this population of devices, a potential savings of $3 M per year could result. It is recognized, however, that some States have already implemented increased oversight programs for generally licensed devices.
l Improved tracking for devices distributed in the future, as well as improved awareness by general licensees of their responsibilities, expected to result from this rulemaking, will also help l to reduce future smelting incidents.
There are other costs, though less significant, associated with lost sources which could be reduced by this rulemaking.-
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in addition to registration, or comparable controls implemented under Agreement State regulations for certain devices, there are additional provisions in this rule that are expected to improve accountability and compliance with existing regulations for all devices generally licensed under 9 31.5 and equivalent regulations of the Agreement States, particularly those l distributed in the future. Although the criteria chosen for determining which devices should be subject to a. registration requirement are intended to include those devices that present the most risk of significant costs or significant exposures to the public if lost or improperly disposed
- of, other generally licensed devices present similar though lesser risks.
- The proposed revisions that are intended to allow NRC and the Agreement States to better track the location of generally licensed devices would maintain the regulatory bodies' ability to contact and inspect the general licensees. The proposed provisions would also allow the tracking of indmdual devices. This will aid the enforcement of regulations anet the identification of the persons responsible for devices that are found in inappropriate places.
The rulemaking should thus reduce the number of orphaned sources. The cost of disposalin the case of orphaned sources falls on parties otner than the user of the device, such as !
govemment agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently I come into possession of a device. .
l These projected savings would not be entirely attributable to implementation of the rule, but also to the planned increase in inspection and enforcement efforts.
Additional Benefits from 9 31.5(c)(15):
The ALARA principal is one basis for alleviating the need for leak testing and shutter testing while a device is in storage. Indeed, it is an unt'ecessary exposure to personnel who perform such tests since, prior to removing the device from storage, the device must be checked.
Reduend burden on general licensees to perform activities while a device is in storage, resulting in expo Jre benefit and cost savings.-- Also, decreases the likelihood of loss of control of a device due to a fixed time period of storage of such devices. Devices that are in storage for
! long periods of time (i.e., greater than 2 years) are more likely to be forgotten and end up being improperly transferred or inadvertently discarded.
Assumptions:
General Licensees:
Number of 6 31.5 GL devices: 600,000 Percentage of devices requiring leak tests and shutter tests every 6 months: 10%
Percentage of devices in long term storage: 3%
' Time per year to perform leak test and shutter test per device (assuming 15 minutes every 6 months): 0.5 hrs Technical staff hourly rate: $50/hr 1
Total Cost Savings (per year): $45,000 1
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r-Note that there is not strict compatibility of this requirement for Agreement States, however if there are similar changes made to an Agreement State's regulations, similar savings would result, potentially for a larger number of devices.
6 DECISION RATIONALE lt is recommended that this action be adopted because it represents a reasonable means for the Commission to fulfillits obligation to protect public health and safety, property, and the environment. It would be implemented to better ensure that certain general licensees are aware of those requirements with which they must comply, and to provide a more complete system for NRC and the Agreement States regulatory bodies to keep track of the location of their general licensees as well as track individual devices. The rationale for this recommendation follows.
It is estimated that adoption of this regulatory action would result in up-front development and implementation costs to the Commission and to Agreement States of $504,000 and $3,750,000 respectively. Also, estimated annual costs would be $2,282,000 to industry, $107,700 to the Commission and $83,000 to Agreement States. These costs are appropriate considering;
- 1) the nominal cost per device and full cost recovery requirement,2) the averted radiation exposure, 3) savings in cleanup costs, and 4) increased confidence in the efficacy of the generallicense program.
First, almost the entire cost to licensees is the imposition of fees. This is being done as a matter of equity and is shifting a portion of the overall costs of implementing and enforcing the generallicense requirements from specific licensees to some of the general licensees who benefit from the general license program. The cost being recovered from the general licensees is not limited to those for implementing these revisions to the general license program; instead, the cost to generallicensees consists of the cost of that fraction of the overall generallicense program associated with the devices subject to the registration requirement. Since the requirement for full cost recovery was enacted, all costs of the general license program have been recovered from specific licensees. The cost estimate used to develop the amount of the fee includes an estimate of increased inspection and follow up efforts expected to be made as a result of the registration process identifying noncompliance with existing regulations. That cost will now be passed on to the generallicensees associated with the registration requirement. It is also expected that this cost will decline after the initial implementation of the registration process, in which case, this fee might be reduced in the future.
Although the total cost to affected general licensees of $2,200,000 is significant, the fee per generallicensee is $370, which amounts to an average of $92 per device. The economic impact of this fee is not believed to be significant, especially in comparison to the fees placed upon specific licensees.
Second, the results of the General License Study conducted by the NRC indicated that there is noncompliance with the generallicense requirements contained in @ 31.5(c). The Study revealed that a major reason for noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements associated with the possession and use of these devices that must be met. Such noncompliance presents a risk of low but avoidable 25 V- .
exposure of the public to radiation plus a low probability of significant exposure as a consequence of improper handling or disposal of the devices generally licensed.
Third, this regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions associated with the general license and comply with the applicable regulatory requirements. It is believed that increased awareness and understanding of the NRC's requirements on the part of the generallicensees willincrease the likelihood that general licensees will comply with those requirements and thereby prevent costs to industry, and to State govemment agencies, from improper handling or disposal of generally licensed devices. The benefit to be realized even further overshadows the small costs when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs which have occurred because of past improper disposition of generally licensed devices.
And finally, promulgation of this rule should result in improvement in the accountability for devices and would provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.
7 IMPLEMENTATION The regulatory action is not expected to present any significant implementation problems. me revised computer database system which will include the capability of processing registrations ;
is already being developed. General licensees will be sent a copy of the final Federal Register notice.
8 EFFECT ON SMALL ENTITIES The action would have an economic impact on general licensees of devices containing byproduct material. There are up to 45,000 general licensees under @ 31.5 of which 6000 would be required to register devices and pay a fee, many of whom may be "small entities" within the meaning of the Regulatory Flexibility Act (Pub. L.96-534). The specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in the earlier proposed rule. With the exception of the fee, the provisions would add no further, or minimal impact than that already planned and accounted for under the previous proposed rule. Therefore the economic impact on small entities would be the incurrence of the fee, in the proposed amount of $370 (about $92 per device on average). The economic impact on the small entities are not believed to be significant. Many of the distributors of generally licensed devices are not small entities and the impact to any of these distributors are not expected to be significant in any case.
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1 ATTACHMENT 7 Congressional Letters t
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@ uto O' 4 UNITED STATES i
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205f50001 The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
i Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking .
to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) l is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to: (a) explicitly require that certain general licensees register certain devices that they have received for use under a
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i generallicense and (b) add a registration fee. NRC plans to institute this registration system under an earlier proposed rule for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, and labeling pertaining to these generally licensed devices.
NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to better account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, .,
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham l
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.p t UNITED STATES 2 E NUCLEAR REGULATORY COMMISSION f WASHINGTON, D.C. 20$65 0001
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The Honorable Joe L. Barton, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to: (a) explicitly require that certain general licensees register certain devices that they have received for use under a general license and (b) add a registration fee. NRC plans to institute this registration system under an earlier proposed rule for devices using certain quantities of specific radionuclides that are primarily used in cnmmercial and industrial applications. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, and labeling pertaining to -
these generally licensed devices.
NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to better account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Representative Ralph M. Hall L- . . . .- . ..
The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, .
Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
j Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking j to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) l is proposing to amend 10 CFR Parts 30,31,32,170, and 171 to: (a) explicitly require that l certain general licensees register certain devices that they have received for use under a
- general license and (b) add a registration fee. NRC plans to institute this registration system under an earlier proposed rule for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, and labeling pertaining to these generally licensed devices.
NRC has observed a number of instances in the past where generally licensed devices have not l been properly handled or disposed of. This amendment would allow NRC to better account for i devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of .
workers or the public and is not expected to impose a significant burden on licensees. I Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Identical letter sent to: The Honorable Joe L. Barton Federal Registr,r Notice cc: Senator E>ob Graham !
DISTRIBUTION: NMSS Ticket Nos.199800204 and 205 EDOrM MBridgers CPoland CRMattsen NMss Dir. Off. r/f ' JMcCausland DACool lo:\MATTsEN\GL2P\GL2PCON} Edited by E. Kraus 3/26/99 l OFFICE RGBilMNs l RGB\lMNs l D:IMNs l TechEd l D:NMss l OCA l lNAME CMattsen PHolahan DCool EKraus' CPaperiello DKRathbun l DATE / /99 / /99 / /99 3/26 /99 / /99 / /99
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ATTACHMENT 8 Draft Press Release o
DRAFT NRC PROPOSES ADDITIONAL REQUIREMENTS FOR CERTAIN DEVICES CONTAINING RADIOACTIVE MATERIAL The Nuclear Regulatory Commission is proposing to amend its regulations to establish additional requirements for users and distributors of radioactive materialin certain measuring, gauging and controlling devices.
The revisions are r.imed at providing greater assurance that users of the devices will properly handle and dispose of them, thus reducing the potential for unnecessary radiation exposure to the public or contamination of property.
The proposed revisions would provide the details of an annual registration program that the NRC plans to initiate. The changes would also require that dist'ihan:s provide additional information to users to provide further assurance that they understand the requirements for possession of the devices.
Companies and individuals are permitted to use the devices under an NRC
" general license," which means that they need not have a specific license issued to a named individual or organization with specific license conditions and requirements. A l generally licensed device usually consists of radioactive material contained in a sealed source within a shielded container. A common example is a fixed gauge used in a factory to monitor a production process and ensure quality control.
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Such a device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of radiation training or experienco of each user is not necessary.
In the past, NRC has not i sgularly contacted general licensees because of the relatively small radiation risk posed by the devices. However, there have been a number of instances in which generally licensed devices have not been properly handled or properly disposed of.
The proposed registration requirement would apply to generally licensed measuring, gauging and controlling devices with quantities of certain radioactive materials posing a higher risk to public safety or of property damage if the device were lost than would other generally licensed devices.
The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density, or chemical composition in industries such as petrochemical and steel manufacturing. About 6,000 general j licensees possessing about 24,000 devices would come under the registration requirement.
General licensees affected by the registration requirement would have to pay the NRC an annual registration fee of $370.
Specific licensees who distribute the measuring, gauging, and controlling devices would be required to provid: Mfore transferring a device to a general licensee-copies of additional applicable sections of the NRC regulations, a listing of the types of service to the device that can only be performed by a specific licensee, and information
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regarding disposal options, including the cost for disposal. The amendments would also modify the reporting, recordkeeping, and labeling requirements for distributors.
The Commission has established an interim enforcement policy for violations of NRC regulations that general licent;as discover and report during the initial cycle of the registration program. The interirn policy provides that enforcement action normally will not be taken for violations so iderdbd and reported, provided appropriate corrective action has been taken. This amnesty period, which will remain in effect through one complete cycle of the registration program, should encourage general licensees to search their facilities to ensure that sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective actions when deficiencies are found.
The Commission also plans to increase the civil penalty amounts that would be -
imposed for violations involving lost or improperly disposed-of devices or radioactive material from them. This increase will better relate the civil penalty amount to the costs avoided by the failure to properly dispose of the source or device.
Additional cietails of the proposed revisions to the regulations are contained in a Federal Register notice to be published shortly. Interested persons are invited to submit written comments within 75 days of the Federal Register notice to the Secretary, U.S.
Nuclear Regulatory Commission, Washington, D.C. 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments may also be submitted via the NRC's interactive rulemaking web site through the NRC home page at http://www.nrc.cov. Information on this site is available from Carol Gallagher, 301/415-5905; e-mail CAG @ nrc.aov.
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ATTACHMENT 9 Form XXX - Transfers of Industrial Devices Report
PT 3 o
[ 7. In Q 31.5, paragraphs (b), (c)(5),(c)(8), and (c)(9) are revised and paragraphs (c)(12),
(13), (14), and (15) are added to read as follows:
$ 31.5 Certain measuring, gauging, or controlling devices.8
' (b)(1) The general license in paragraph (a) of this section applies only to byproduct
! material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in -
(i) a specific license issued under 32.51 of this chapter; or (ii) an equivalent specific license issued by an Agreement State.
(2) The devices must have been received from one of the specific licensees described in paragraph (b)(1) of this section or through a transfer made under paragraph (c)(9) of this section.
(c)
(5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie or more removable radioactive material. The device may not be operated untilit has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under parts 30 and 32 of this chapter or by an Agreement State. The device may be disposed of by transfer to a person authorized by a specific license to receive the 8
Persono possessing byproduct material in devices under a general license in @ 31.5 before
' January 15,1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of $ 31.5 in effect on January 14,1975.
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. r byproduct material contained in the device. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie or more
' removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days. Under these circumstances, the criteria set out in S 20.1402,
" Radiological criteria for unrestricted use." may be applicable, as determined by the Commission on a case-by-case basis; 3
(8) (i) Shall transfer or dispose of the device containing byproduct material only by transfer to another general licensee as authorized in paragraph (c)(9) of this section or to a person authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, part 30 of this chapter that authorizes waste collection, or equivalent regulations of an Agreement State, or as approved under paragraph (c)(8)(iii) of this section.
(ii) Shall fumish a report to the Director of Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days after the transfer of a device to a specific licensee. A report is not required if the device is transferred to the specific licensee in order to obtain a replacement device from the same specific licensee. The repost must contain -
(A) The identification of the device by manufacturer's name, model number, and serial number; (B) The name, address, license number of the person receiving the device; and (C) The date of the transfer.
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(iii) Shall obtain written NRC approval before transferring the device to any other specific licensee.
(9) Shall transfer the device to another general licensee only if:
(i)The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this section and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report the manufacturer's name and the model number and the serial number of the device transferred, the name and address of the transferee, and the name and phone number of the responsible individual identified by the transferee in accordance with paragraph (c)(12) of this section to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; or (ii) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.
(12) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with
. appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of responsibility in this regard.
(13)(i) Shall register devices containing at least 370 MBq (10 mci) of cesium-137, 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of americium-241 or any other transuranic, i.e., element with atomic number greater than uranium (92), in accordance with paragraphs (c)(13)(ii) and (iii) ^f this section.
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e i (ii) If in possession of a device meeting the criteria of paragraph (c)(13)(i) of this section, shall register these devices annually with the Osmmission and shall pay the fee required by 6 170.31 of this chapter. Registration must be done by verifying, correcting, and/or adding to
. the information provided in a request for legistration received from the Commission. The registration information must be submitted to the NRC within 30 days of the date of the request for registration or as otherwise indicated in the request, in addition, a general licensee holding devices moeting the criteria of paragraph (c)(13)(i) of this section is subject to the bankruptcy notification requirement in $.30.34(h) of this chapter.
(iii) in registering devices, the general licensee shall furnish the following information
, and any other information specifically requested by the Commission:
(A) Name and mailing address of the general licensee.
. (B) Information about each device: the manufacturer, model number, serial number, the radioisotope and activity (as indicated on the label).
. (C) Name and telephone number of the responsble person designated as a representative of the generallicensee under paragraph (c)(12) of this section.
(D) Address at which the device (s) are used and/or stored. For portable devices, the
. address of the primary place of storage.
1 (E) Certification by the responsible representative of the general licensee that the information conceming the device (s) has been verified through a physical inventory and
- checking of labelinformation.
(F) Certification by the responsible representative of the general licensee that they are
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aware of the requirements of the generallicense.
(14) Shall report changes of address to the Director of Nuclear Material Safety and I
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days 44 1
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1 a after the moving of a device, if it is a portable device, this report only applies to a change in the device's primary place of storage.
(15) May not hold devices that are not in use for longer that 2 years. If devices with
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shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. j PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR l
TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL l
- 8. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81,161,182,183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).
- 9. In @ 32.51, paragraphs (a)(4) and (5) are added to read as follows:
9 32.51 Byproduct material contained in devices for use under 9 31,5; requirements for license to manufacture, or initially transfer.
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(4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, " Caution-Radioactive Material,"
the radiation symbol described in Q 20.1901 of this chapter, and the name of the manufacturer or initial distributor.
(5) Each device meeting the criteria of @ 31.5(c)(13)(i) of this chapter, bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words,
" Caution-Radioactive Material," and, if practicable, the radiation symbol described in @ 20.1901 of this chapter.
- 10. Section 32.51a is revised to read as follows:
9 32.51a Same: Conditions of licenses.
(a) If a device containing byproduct materialis to be transferred for use under the generallicense contained in 31.5 of this chapter, each person that is licensed under 9 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes -
(1) A copy of the general license contained in 31.5 of this chapter; 46
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(2) A copy of @@ 31.2,30.51,20.2201, and 20.2202 of this chapter; (3) A list of the services that can only be performed by a specific licensee; and (4) Information on acceptable disposal options including estimated costs of disposal.
(b) If byproduct materialis to be transferred in a device for use under an equivalent general license of an Agreement State, each person that is licensed under @ 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device raay be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes --
(1) A copy of the Agreement State's regulations equivalent to 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy of 9 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a copy of the NRC regulations is provided to a prospective generallicensee, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; (2) A list of the services that can only be performed by a specific licensee; (3) Information on acceptable disposal options including estimated costs of disposal; and (4) The name, address, and phone number of the contact at the Agreement State regulatory agency from which additionalinformation may be obtained.
(c) Each device that is transferred after (insert date 1 year after the effective date of this rule) must meet the labeling requirements in 32.51(a)(3) through (5).
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e (d) If a notification of bankruptcy has been made under @ 30.34(h) or the license is to be terminated, each person licensed under S 32.51 shall provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under S 32.52(c).
- 11. Section 32.52 is revised to read as follows:
S 32.52 Same: material transfer reports and records.
Each person licensed under @ 32.51 to initially transfer devices to generally licensed persons shall comply with the requirements of this section.
(a) The person shall report all transfers of devices to persons for use under the general license in 31.5 of this chapter to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The report must be submitted on a quarterly basis on Form XXX " Transfers of Industrial Devices Report" or in a clear and legible report containing all of the data required by the form.
(1)The required information includes --
(i) The identity of each general licensee by name and mailing address for the location of use; (ii) The name and phone number of the person identified by the generallicensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer; (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device.
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+. e (2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same
, information for both the intended user and each intermediate person, and clearly designate the
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intermediate person (s).
'(3) If a device transferred replaced another returned by the general licensee, the report must also include the type, model number, and serial number of the one returned.
(4) The report must cover %:h calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
(5) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.
(6) If no transfers have been made to persons generally licensed under 6 31.5 of this chapter during the reporting period, the report must so indicate.
(b) The person shall report all transfers of devices to persons for use under a general i
license in an Agreement State's regulations that are equivalent to f 31.5 of this chapter to the responsible Agreement State. agency. The report must be submitted on Form XXX " Transfers of Industrial Devices Report" or in a clear and legible report containing all of the data required '
by the form.
('s) The required information includes --
(i) The identity of each greneral licensee by name and mailing address for the location of use;
- (ii) The name and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer; i
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l (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device.
(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person (s).
(3) If a device trancierred replaced another returned by the general licensee, the report must also include the type, model number, and serial number of the one returned.
(4) The report must be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person and clearly indicate the period covered by the report.
(5) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.
(6) If no transfers have been made to a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the agency.
(c) The person shall keep records of all transfers of devices for each general licensee including all the information in the reports required by this section and records of final disposition. - Records required by this paragraph must be maintained for a period of 3 years following the estimated usefullife of the device or the date of final disposition,if known.
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PART 170 - FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED
- 12. The authority citation for Part 170 continues to read as follows:
Authority: 31 U.S.C. 9701; sec. 301, Pub. L. 92 - 314,86 Stat. 222 (42 U.S.C. 2201w);
l sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841); sec. 205, Pub. L.101 - 576,104 Stat.
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2842, (31 U.S.C. 9012).
- 13. Section 170.2 is amended by adding a paragraph (r) to read as follows:
9170.2 Scope.
(r) A holder of a generallicense granted by 10 CFR Part 31 who is required to register a device (s). ;
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- 14. In 6170.3, the definition of Materials Ucense is revised to read as follows:
$ 170.3 Definitions.
Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR parts 30,31 through 36,39,40,61. 70,71 and 72.
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- 15. Section 170 31 is amended by adding a fee category,3. Q. to the schedule of materials fees and amending footnote 1 to add a paragraph (f).
9 170.31 Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses.
Schedule of Materials Fees
[See footnotes at end of table)
Category of materials licenses and type of fees' Fee 22 3.
O. Registration of a device (s) generally licensed pursuant to Part 31.......... .................$370
' Types of fees (f) Generallylicensed device registrations under 10 CFR 31.5. Submittals of registration information must be accompanied by the prescribed fee.
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Part 171 - ANNUAL FEES FOR REACTOR OPERATING LICENSES, AND FUEL CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC
- 16. The authority citation for Part 171 continues to read as follows:
Authority: Sec. 7601, Pub. L.99-272,100 Stat.146, as amended by sec. 5601, Pub. L.
100-203,101 Stat.1330, as amended by sec. 3201, Pub. L.101-239,103 Stat. 2106 as amended by sec. 6101, Pub. L. :01-508,104 Stat.1388 (42 U.S.C. 2213); sec. 301, Pub. L.92-314,86 Stat. 222 (42 U.S.C. 2201(w)); sec. 201,88 Stat.1242 as amended (42 U.S.C.
5841; sec. 2903, Pub. L.102-486,106 Stat. 3125 (42 U.S.C. 2214 note).
- 17. In 6171.5, the definition of Materials License is revised to read as follows:
9171.5 Definitions.
Materials License means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC pursuant to the regulations in 10 CFR Parts 30,31 through 36, 39, 40, 61, 70, 71, and 72.
- 18. In Section 171.16, paragraph (d) is revised by adding a fee category,3. O. to the schedule of annual fees.
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- a 9171.16 Annual fees: Material Licensees, Holders of Certificates of Compliance, Holders of Sealed Source and Device Registrations, Holders of Quality Assurance Program
. Approvals and Government Agencies Licensed by the NRC.
Schedule of Materials Annual Fees and Fees for Government Agencies Licensed by NRC
[See footnotes at end of table]
Category of materials licenses Annual fees'##
- 3. -
O. Registration of devices generally licensed pursuant to Part 31.......... .. ..............."N/A "No annual fee is charged for this category since the cost of the general license registration program will be recovered through 10 CFR Part 170 fees.
Dated at Rockville, Maryland, this day of 1999.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook, Secretary of the Commission.
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! ATTACHMENT 4 l
l l Resource Estimate for General License Program i
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L j Resource Estimates for General License Procram The table below includes the resources necessary for development and implementation of the registration program for the approximate 6000 general licensees for which registration is planned.
Nd%$ N hc bhb,w , 4 FY991 QFYOOK I W b1 M $ 02? lFYOSF hm y ~ e . -
Mdp" wD 6@r
, ,,.z ..
MPs. ~ iFTE LSK7 :FTEi TSKe :FTEd A$Kf fFTE ?$K1 ;FTE: a$K3 Total for Each FY ~ 8.6 910 8.4 720 9 580 9 480 5 480 Rulemaking - First Rule - 0.7' O O O O O O O O O Rulemaking - Second Rule ' 2.0' O 1.5 0 0 0- 0 0 0 0 Follow-up on Returned Mail from ' 1.25 250 0 0 0 0 0 0 0 0 Rule 1 (Proposed)
Automated System Development 1.1' 420 0.8 280 0 0 0 0 0. O through Deployment Guidance, Procedure, and 3.5' 100 0.4 0 0 0 0 0 '0- 0 Program Development and.
Contract Management * .
I implementation of Tracking and Registration Program:
-. Registration Mailings / Data 0' 140 2 440 2 580 2 480 2 480 Input / Initial Follow-up NRC Follow-up Inspections 0 0- 4.2 0 7 0 7 0 3 0 g7 The staff notes the following about the resources included in the table:
e The staff notes that the resources listed in the table exceed the total number of resources '
identified in the FY99 NMSS budget for the general license registration program.
Specifically, some of the resources in the table are included in other budget categories (e.g.,
rulemaking, licensing guidance) or are included in the budget of other offices (e.g., OClO for automated system development).
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~e The table includes resources to account for a substantial spike of resources needed in the ,
? initial years of program implementation. This spiks of resources is needed to perform follow-up actmties with general licensees that do not respond to registration requests or cannot account for all their devices. The staff has accounted for this spike in 2 ways. First, .
the contractor that will maintain the registration program will perform the initial follow-up
This includes some resources expended in FY 98. This also includes resources expended by offices other than NMSS. !
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activities for these licensees. Second, the staff plans to defer some follow-up inspections, that would be performed by regional staff, until the second or third year of implementation.
Specifically, the staff estimates that it would need 9 FTE in the first,6 FTE in the second year, and 3 FTE !n the first third year for follow-up inspections by NRC staff. Instead, NRC plans to have all rokw-up inspections completed by the end of the third year of implementation and will prioritize follow-up inspections based on the risk associated with loss of the material and the probability of locating the device.
- The staff is still exploring the possibility of contracting with the States to carry out some of the follow-up activities. However, the resource impact of States performing inspections is not accounted for in the table.
The staff is stillin the process of exploring the possibility of utilizing other Federal agency registration programs and off-the-shelf commercial programs to minimize development and operating costs. However, the resources in the table are based on the estimated cost for complete development of an updated general license tracking system including automated registration program.
e The staH notes that line
- of the table includes resources for follow-up activities with licensees that would be subject to registration for which a copy of the December.2,1998, Federal Register Notice that noticed the first proposed rule was not deliverable. The NMSS budget did not include resources for these fo,Ilow-up activities in FY99. Resources for these activities came from regional inspection resources for event response and regional initiatives.
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' ATTACHMENT 5 -
Impact of Converting Portable Moi.sture Density Gauges to Registered Generally Licensed Devices on Resources and Timeline
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L impact on Resources and Timeline of Converting Portable Moisture Density Gauges to Registered Generally Licensed Devices To estimate the resource impact'on the materials program, including the proposed registration program, the staff needs to consider the number of NRC licensees that may be effected by allowing the use of portable moisture density gauges under a general license. The staff estimates that there are currently 1100 licensees' using portable moisture density gauges under an NRC specific license. If all types of portable moisture density gauges were approved for use under a generallicense, the staff estimates that 80% of the current specific licensees, approximately 880 of these licensees, would terminate their specific license and would possess the gauges under a general license. These 880 licensees possess approximately 5000 portable moisture density gauges. The remaining licensees (i.e., the otMr 20%) would -
continue to use the gauges under a specific license since they perform other activities that would still require a specific license. Persons possessing the gauges under a generallicense L would be subject to the proposed annual registration program. The staff estimates the following impacts on the materials program, including the proposed registration program:
initial Costs O.3 FTE and $75K for adding the vendor, licensee, and gauge information to the generallicense tracking system.
1.0 FTE to terminate existing specific licenses. This would have an impact on the materials licensing program.
It is estimated that these initial costs would occur over a 3-year period.
Annual Costs 0.2 FTE and $60K to annually register the 880 general licensees.
NRC would save 3.0 FTE in licensing and inspectiori activities.
Overall, the materials program would need to reprogram current licensing and inspection i resources to implementation of the proposed registration program and termination of specific !
licenses. This would have no impact on the timeline for development and implementation of the proposed registration program. After conversion of alllicensees is complete, the materials '
program would experience an overall savings in licensing and inspection resources. The table ,
below includes an estimate of the resource changes to the current materials program. The '
table assumes that one-third of the initial costs will be experienced in each of the first 3 years and that one-third and two-thirds of the ultimate annual costs will be experienced in the first 2 years, respectively.
Year 1 2 3 4 5 FTE -0.5 -1.4 -2.4 -2.8 -2.8
$K 45 65 85 60 60
' This is the current number of NRC specific licensees using protable moisture density i gauges. The estimates in this attachment did not account for a decrease in the number of licensees due to new Agreement States coming on line.
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ATTACHMENT 6 Regulatory Analysis
1 REGULATORY ANAL'YSIS:
l l REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL
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L 1 STATEMENT OF THE PROBLEM . . . . . . . . . . . . . . . . . . . . .'. . . . . . . . . . . . . . . . . . . . . 1 1.1- BAC KG R O U N D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 NRC Study of Conformity with General License Conditions . . . . . . . . . . . . . . . 1 1.2.1 - Part i Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1.2.2 Part 11 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1.3 Subseq uent Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 OBJ E CTI VE S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3 ALTE R NATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.1 No a ction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.2 Non-rulemaking altematives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3.3 Rulemaking to modify distributors labeling, reporting, and record keeping requirements and add additional provisions to the 6 31.5 general license . . . . 7 l 4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES . . . . . . . . 7 4.1 Revisions to the Requirements for General Licensees in 9 31.5 . . . . . . . . . . . 7 A. . Registration: Certain measuring, gauging or controlling devices
($ 31.5(c)(13)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 B. Responsible Individual: Certain measuring, gauging or controlling devices ($ 31.5(c)(12)) .................................... 8 C. Storage: Certain measuring, gauging or controlling devices
! (6 31.5(c)(15)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 D. Transfers of Devices: Certain measuring, gauging or controlling devices (Revision to 6 31.5(c)(8)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 E. Notification Requirements: Certain measuring, gauging or controlling devices ($ 31.5(c)(14)) ................................... 10 F. Decommissioning Requirements: Certain measuring, gauging or controlling devices (Revision to 6 31.5(c)(5)) . . . . . . . . . . . . . . . . . . . 11 G. . Reports of Transfer to another general licensee at same premises (Revision to f 31.5(c)(9)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 H. Limitation of Applicability of General License (Revision to f 31.5(b)) . 12
- 1. Bankruptcy: Terms and conditions of licenses (Revision to 6 30.34 (h)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 J. Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses (Revision to 6 170.31 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 K. Impact to General Licensees in Agreement States due to Compatibility Requirements for f 31.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4.2 ' Requirements for Manufacturers and initial Distributors of Devices ....... 14 A.' .
Quarterly Reports: Material transfer reports and records (6 32.52(a) and (b)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 B. Retention: Material transfer reports and records ($ 32.52(c)) . . . . . . . 15 C. Records: Conditions of licenses (6 32.51a(d)) . . . . . . . . . . . . . . . . . . 16
- D. Labeling: Byproduct material contained in devices for use under 6 31.5;
' requirements for license to manufacture, or initially transfer ( 32.51(a)(4) and (5) and f 32.51 a(c)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 i
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E. Information provided to general licensees: Conditions of licenses (9 32.51 a(a) and (b)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 4.3 Clarifying and Conforming Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 A. Types of ficenses (Q 30.31 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8 B. Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of 1954, as amended (Pa d 170) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 C. Annual Fees for reactor operating licenses, and fuel cycle licenses and materials licenses, including holders of certificates of compliance, registrations, and quality assurance program approvals and government agencies licensed by NRC (Part 171) . . . . . . . . . . . . . . . . . . . . . . . . . 18 4.4 Summary of Estimated Annual Costs of Proposed Rule . . . . . . . . . . . . . . . . 19 4.5 Annual Costs to Agreement States of Compatible Regulations . . . . . . . . . . . 19 4.6 Development and Implementation Costs. . . . . . . . . . . . . .............. 20 5 BENEFITS OF PROPOSED RULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 5.1 Summary of Benefits of Proposed Alternative . . . . . . . . . . . . . . . . . . . . . . . . 21 5.2 Summary of Radiation Exposure Averted Benefit . . . . . . . . . . . . . . . . . . . . . 22 5.3 Summary of Economic Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 6 DECISION RATIONALE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 7 lMPLEMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 8 EFFECT ON SMALL ENTITI ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 ii l
1 i: 1 STATEMENT OF THE PROBLEM
1.1 BACKGROUND
On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) amended its regulations to provide a general license to possess and use byproduct material in certain
~ devices designed and manufactured 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 devices had to be manufactured in accordance with the specifications contained in a specific license issued either by the Commission under 10 CFR Parts 30 and 32, or by an Agreement State.
Today, there are approximately 45,000 " general licensees," i.e., persons possessing and using such devices under the general license (9 31.5). These general licensees possess an estimated 600,000 devices.
A general licensee under the jurisdiction of the Commission is required to follow safety instructions 'on device labels and to test or service a device (with some exceptions) or to have i the testing or servicing performed by the supplier or other specific licensee authorized to l- _ manufacture, install, or service the devices. Additionally, general licensees may not abandon .
l- - devices, and must maintain records conceming the testing and servicing of these devices. -
- Further,6 31.5(c)(8) requires general licensees to transfer or dispose of the generally licensed devices only to the holder of a specific license under Parts 30 and 32 or to the holder of a .
specific license issued by an Agreement State. Section 31.5(c)(9) provides a limited exception 4 to this requirement that allows general licensees to transfer the devices to other general licensees, but only if the device remains in use at a particular location or the device is held in l storage in the original shipping container before initial use. In either case, transfers of devices
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by general licensees must be reported to the NRC within 30 days of the transfer. No report of a transfer is required if a generally licensed device is transferred to a specific licensee in order to obtain a replacement device. General licensees must also report damage to or loss of devices. ,
L L Specific licensees making the transfer of generally licensed devices are required as part of its specific license to maintain records of the transfer and to be accountable for all radioactive material in its possession. The NRC is notified by specific licensees when these licensees L transfer devices containing byproduct material to general licensees through quarterly reports i submitted under 6 32.52(a). These reports identify each general licensee by name and address
' (including, for an organization, the name or position of a person who may act as a point of contact between the NRC and the general licensee); the type of device transferred; and the i quantity and type of byproduct material contained in the device. Under compatible Agreement I' State regulations, similar information is obtained from suppliers in Agreement States on transfers to NRC generallicensees.
l 1.2 - NRC Study.of Conformity with General License Conditions
' The NRC traditionally h' as had little contact with generallicensees. The NRC staff believes that i
this may account for why many general licensees are not aware of their responsibilities under a j L , general license. The NRC staff believes that this contributes to incidents of mishandling and i improper disposition of generally licensed devices. Mishandling and improper disposition of 1
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m generally licensed devices has, on occasion, resulted in radiation exposure to the public and, in some cases, has entailed expensive investigation, cleanup, and disposal activities. In most instances, exposures to the public have not been significant. However, these exposures would probably not have occurred if the devices had been properly handled and disposed of. >
l The Commission conducted a study from 1984 through 1986 (General License Study) to evaluate the effectiveness of the generallicense program. The results of the study were discussed in SECY-87-167, dated July 9,1987, and in SECY-89-289, dated September 14, 1989. Although current regulations ($ 30.52) allow for the inspection of licensees possessing byproduct material, the Commission does not inspect general licensees on a regular basis primarily because of the large number of these licensees and the low risk presented by most of these devices. The Commission's knowledge of whether general licensees are complying with the regulations for the proper use and disposal of generally licensed devices is limited.
Because of the broad range of devices covered under 6 31.5, the study was divided into 2 parts. The first part covered industrial gauging and measuring devices, such as large-scale level, density, and thickness monitors. There were then approximately 10,000 Commission licensed devices in this category containing sources with activities in the 0.5 to 1 curie range.
The second part of the study < covered devices which greatly varied in design and use, such as self-luminous signs, analytical instruments such as x-ray fluorescence spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and level gauges. A summary of the results of the study presented below is based on an unpublished NRC report entitled
" General License Study Report."
1.2.1 Part 1 Results The Part I study included 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices. Some Agreement States also contributed data to the " General License Study." The information gathered by the study, although from a small
-sample of general licensees possessing large-scale gauges, clearly established that there is a compliance problem. The findings of Part I indicated that:
- Approximately 16 percent of these general licensees could not account for all of their gauges.
- A majority of these general licensees either did not notify the NRC of transfers of their gauges or improperly transferred their gauges.
- At least 25 percent of these general licensees were not performing required leak tests or maintaining leak-test records, or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.
- Agreement Statee gorted incidents of thickness gauges being found in landfills and, in one case, even in an abandoned paper mill.
1.2.2 Part il Results Although Part ll of the study covered devices that vary greatly in design and use, the range of problems encountered in Part 11 is exemplified by the problem relating to self-luminous exit signs and beta backscatter gauges. Exit signs, which are one of the most common devices covered by a general license, contain tritium gas that excites phosphorous-coated glass tubes to give off light. They are used in places where wiring of electrical signs would be difficult or 2
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expensive to'do. Beta backscatter gauges contain a small sealed source and a radiation detector that measures how much radiation is reflected back from a material sample. The concem about these devices is the awountability of the removable source which is about one inch in diameter. Ninety-eight interviews were conducted of persons who possess these types of devices. The findings of Part il are summarized below;
- , ; Nonconformity with general license conditions was very widespread.
Only 16 percent of the generallicensees for exit signs were aware of the regulatory requirements.
Manufacturers and distributors frequently under reported the number of exit signs sold to general licensees. General licensees (electrical distributors and contractors) reported having about 30 percent more signs than were listed in quarterly reports of the manufacturers.
Three cases involved missing sources from beta backscatter gauges.
Only 45 percent of those surveyed for backscatter gauges were aware of the l
generallicense conditions.
.. Vendor reports did not accurately reflect the number of radioactive sources in the l possession of generallicensees. When sources were returned by general licensees to the manufacturer for disposal, the NRC was not always notified.
. Hence, NRC records were not always accurate.
l 1.3 Subsequent Actions
- On December 27,1991 (56 FR 67011)' the NRC published a notice of proposed rulemaking l
, regarding the accountability of general licensees under.$ 31.5. It proposed a number of provisions, including a requirement for these licensees to provide information at the request of the NRC in order to provide the regulatory basis for the registration of these devices. The proposed rule also would have added requirements in 69 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the general licensees. Although the public comments received were reviewed and a final rule developed, that rule was not 1 issued because resources to implement the proposed rule properly were not available.
The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of l>oth NRC and Agreement State personnel and
. encouraged the involvement of all persons haviag a steke in the process and its final recommendations. All working group meetings nre open to the public. A final report was completed in July of 1996 and published in Octobemf 1996 as NUREG-1551," Final Report of
- the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed .
Devices."
. One of the conclusions of the working group is that general licensees possessing certain
. identified devices should report annually to their regulatory authority a listing of their current inventory of devices so as to allow the regulator to independently verify that the licensee has maintained accountability and control of the devices. This was the basis for the recent rule
, proposed on December 2,1998 (63 FR 66492) which would revise Part 31 to add an explicit
' requirement that general licens6x under f 31.5 respond to requests from NRC for information.
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' ine intent is to use that provision to institute a registration program for devices recommended by.the Working Group for enhanced regulatory oversight.
The additional recommendations of the working group provide the major basis for this rulemaking,' which, among other things, would provide more explicit provisions with regard to a registration program. For general licensees using devices containing at least 10 mci of cesium-137,0.1 mci of strontium-90,1 mci of cobalt-60, or 1 mci of any transuranic, the working group recommended the following:
- Licensees must assign a Responsible Individual (RI) and a Backup Responsible individual (BRI).' The RI and BRI must each be an individual that has the
. authority and responsibility for compliance.
- Licensees must pedorm, at intervals not to exceed 6 months and maintain records of; (1) physicalinventories of devices including reconciliation of any discrepancies with previous inventories, and (2) inspections of each device for .
proper labeling including correction of any deficiencies.
- Licensees must keep current inventory records.
- Licensees must report changes concerning the RI and BRI and transfers or disposal of devices.
Licensees must report immediately following the filing of a voluntary or involuntary petition for bankruptcy.
For vendors of the same devices, the working group recommended the following:
- Vendort. must report transfers quarterly and the report must include the name, telephone number, and mailing address of the recipient, the address of use of
- the device, the model number and serial number of the device, the isotope and actiwty, any intermediate holders of the device, including the function of the intermediate holders, the specific reporting period covered by the report, and the
. name and license number of the reporting company.
Vendors must maintain records of transfer for all devices they have distributed, including final disposition, if known. The records must be maintained for 3 years after final disposition of the device.
Vendors must provide recipients with disposal information prior to transfer of the r
device.
! . Vendors must ensure each device, or separable source housing, is labeled with the model number and serial number, the isotope and activity, the trefoil symbol, the words " Caution - Radioactive Material," and the name of the device vendor.
- . Vendors must ensure that source housings are permanently marked (e.g.,
engraved or embossed) with the trefoil symbol and the words " Caution -
Radioactive Material," as practicable.
For both NRC and Agreement States, the working group recommended the following:
. NRC and Agreement States must verify that all transfers by their users are in accordance with their regulations and license conditions.
NRC and Agreement States must compare the annual inventories reported by their users against previous inventories and against transfer reports from vendors and other users. This provides an independent verification that licensees have maintained accountability and control of the devices.
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NRC and Agreement States must resolve any discrepancies in the information with the assistance of the licensees.
- a. NRC and Agreement States must acknowledge to their licensees that the transfers and inventories have been reviewed. '
l 2 OBJECTIVES The dojectives of the amendments to Parts 30,31 end 32 of the Commission's regulations are ;
. (1) to ensure that certain general licensees are aware of and understand the requirements i attendant to the possession of generally licensed devices containing byproduct material and to ,
better enable the NRC to verify the location, use, and disposition of such devices; (2) to j improve NRC's tracking of general licensees; and (3) to add the ability to track individual devices.
The primary intent is to reduce the possibility of the devices being improperly transferred or inadvertently discarded and, ultimately, to avoid unnecessary radiation exposure to the public i and unnecessary expense involved in retrieving the items, particularly in the scrap metal i stream, as well as to avoid the contamination of steel mills, metals, and waste products.
In addition, the objective of the revision of Part 170 to add a registration fee for certain generally ;
licensed devices is equity of fee recovery for the costs of the general license program. J
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3 ALTERNATIVES 3.1 No action. !
i This alternative is to continue the status quo. As costs and benefits are evaluated in terms of changes from the status quo, there are no costs or benefits associated with this attemative. In this case, it is assumed for the purpose of analysis, that Rule 1 is made effective and costs and )
benefits are evaluated as changes from a base case of having that rule in place and implementing a registration program under that provision.
No action, of course, does not address identified concerns. In the past, the only comrnunication i
. between a general licensee and the NRC was through the requirement that the NRC be notified when a device containing byproduct material was transferred. Information notices have been sent and inspections have been made but only rarely.
- As discussed in Section 1.2 of this analysis, general licensees have a lack of awareness of their responsibilities under a generallicense, The NRC staff believes that this lack of awareness is a major contributor to the occurrence of incidents of mishandling and improper disposition of )
generally licensed devices.' This, in tum, has resulted in radiation exposure to the public and, in i some cases, entailed expensive investigation, cleanup, and disposal activities. Rule 1 would begin to address this problem, but in a limited way, it does not require compatibility of :
- Agreement State regulations, so only approximately one-third of generally licensed devices l meeting the criteria for enhanced oversight will be covered. It was estimated in the regulatory I analysis for that action that it would affect about 20 percent of the devices presenting a significant risk in the case of loss (the other 80 percent being generally licensed under i Agreement State regulations or held by specific licensees), it was also assumed that it would i 5 l
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1 conceivably cut the rate of loss within this population by roughly one half, thus reducing the impacts from lost sources by 10 percent. Also, Rule 1 will not completely address the factors discussed in the next section concerning knowledge of the regulations reaching the appropriate persons.
No action would not be appropriate because the factors listed in the preceding paragraph should be addressed.
3.2 Non-rulemaking alternatives With respect to the problem of lack of awareness of regulatory requirements on the part of generallicensees, there are a number of approaches that could be considered. Guidance could be provided in a number of forms. However, periodic contact with the general licensees would be expected to have the most significant impact on the level of awareness of requirements. The most appropriate means to remind users of their responsibilities would be periodic issuance of information notices. However, these information notices may not reach all users. While 6 32.52 requires that specific licensee distributors report to the NRC or the Agreement State agency the n: me and/or title of the individual who constitutes the point of contact between the general licensee and the NRC, or the Agreement State agency, the General License Study indicated that this individual, who is frequently in the purchasing department, often did not inform the individual who uses the device of the general license conditions. Moreover, the study indicated that personnel turnover frequently destroyed the organization's knowledge of the license conditions. For similar reasons, information notices may also not reach the appropriate person within the organization of a general licensee since the contacts provided in the specific licensees' quarterly reports are frequently not the individuals responsible for, or knowledgeable of, the devices after they have been received and are being used. In this case, the initial contact name received from a distributor would continue to not be the person knowledgeable of the device or the regulations and would present problems with the implementation of a registration program in Rule 1. The process will be more efficient if more appropriate contact information is received initially from the distributor.
Even when generallicensees are aware of their basic responsibilities concerning the devices, there may be other factors contributing to noncompliance with requirements. For example, the cost of disposal may cause some generallicensees to dispose of devices improperly. It is important that the general licensees understand that the Commission will hold them responsible for these devices. Increased inspection of generallicensees and enforcement of the requirements may improve compliance. However, without a registration system to verify compliance as well as additional requirements for general licensees such as, appointing a responsible individual, performing inventories, reporting of bankruptcy, time limit on storage of devices, and without additional requirements for vendors such as reporting Ris and serial numbers of devices transferred, providing recipients of disposal costs and maintaining transfer records including final disposition of devices as well as additional labeling requirements, there would not be sufficient regulatory requirements for general licensees to be responsible and accountable for their devices. Also, there would not be a large enough number of inspections and these inspections would be on a random basis and would not be very efficient.
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None of these actions would result in a high degree of accountability for these devices.
Additional regulatory requirements would be more effective in terms of accountability, and would provide a basis for more efficient use of inspection and enforcement efforts.
, l 3.3 - Rulemaking to modify distributors labeling, reporting, and record keeping i requirements and add additional provisions to the 6 31.5 general license This attemative would amend 10 CFR Parts 31 and 32 to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.
The general mechanism to be used would be to add explicit provisions delineating the registration requirement so that general licensees verify compliance with certain conditions ,
imposed by the generallicense. l In addition, the amendments to 10 CFR Part 31 would require a generallicensee to appoint a responsible individual, perform inventories, report bankruptcy, limit the time on storage of devices. Amendments to 10 CFR Part 32 would require vendors to report responsible i individuals and serial numbers of devices transferred, to provide recipients estimates of .
disposal costs, and to maintain transfer records including final disposition of devices. Additional !
labeling requirements would also be included. .
j The NRC envisions that these are elements of a well defined enhanced oversight program.
They offer greater assurance that a general licensee is informed of its regulatory responsibilities and will assign a knowledgeable individual who will provide information to assist with verifying accountability for devices. The NRC would make periodic requests for verification to remind general licensees of their regulatory responsibilities and to reduce the likelihood that devices ;
containing byproduct material are illegally transferred or inadvertently discarded. In addition, for specific licensees who distribute these generally licensed devices, there would be changes in the reporting, recordkeeping, and labeling requirements.
i 4 DESCRIPTION AND DISCUSSION OF PROVISIONS AND COST ESTIMATES 4.1 Revisions to the Requirements for General Licensees in 6 31.5 A. Registration: Certain measuring, gauging or controlling devices (9 31.5(c)(13))
Section 31.5 currently grants a general license to certain individuals and contains the requirements under that license. The proposea rule would add explicit provisions delineating an 1 annual registration requirement. This addition would provide general licensees with the details of the registration requirement including which devices are subject to registration and the kinds of information that will be required to be submitted by this process. Specific provisions proposed here are essentially consistent with the Commission's plans for the registration process discussed in Rule 1. Annual registration is required for devices containing at least 370 MBq (10 mci) of cesium 137,3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any transuranic. This provision would specifically require that
. the information about devices be verified through a physical inventory. The registration information that would be required is as follows:
. Name and mailing address of the general licensee.
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. Information about each device: the manufacturer, model number, serial number, radioisotope, and activity.
. Name and telephone number of the responsible person designated as a
. representative of the general licensee under proposed 6 31.5(c)(12) (discussed below).
.. - Address at which the device (s) are used and/or stored. For portable devices, the address of the primary place of storage.
. Certification by the responsible representative of the generallicensee that the information conceming the device (s) has been verified through a physical
- inventory and checking of label information.
. Certification by the responsible representative of the general licensee that they are aware of the requirements of the generallicense.
Cost Imoacts:
None anticipated.
. The costs to industry and to the NRC of the registration process were addressed in Rule 1 and are not a result of this action. Rule 1 would require generallicensees to respond to requests from the NRC to verify information related to their generally licensed devices. Specifically, it accounted for the costs associated with locating and verifying license conditions for all devices in the possession of general licensees. This rule describes the information that will be required ,
by registrants and would not require more than verification of the current location of all devices and verification of the information as is planned to be requested under the Rule 1.
The advantage of including more explicit requirements in the regulation is that information about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 6 31.5 to its customers (under 6 32.51a(a)), the potential general licensees' will be made aware of the registration requirement, including to which devices it applies, what information will be requested, and also the fact that there will be a fee.
Having more explicit requirements would, if anything, simplify inspection and enfement.
B. Responsible individual: Certab a sasuring, gauging or controlling devices (3 31.5(c)(12))
The proposed rule would add an explicit requirement,6 31.5(c)(12), for the general licensee to appoint an individual to carry out the general licensee's responsibilities to comply with the applicable regulations.-
Cost Impacts:
None anticipated.
While appointing a person to be responsible for performing required actions should already be occurring in practice, this action would explicitly require an identified person be designated. In other words, there must already be a person who performs shutter tests, leak tests, and 8
compliance with regulations. This proposed rule would require generallicensees to designate the person who is to be knowledgeable of the requirements and having the authority to ensure I that shutter tests and leak tests are performed (as well as any other action necessary for f compliance with regulations) as the " responsible individual."
No significant effect on inspection and enforcement is anticipated.
C. Storage: Certain measuring, gauging or controlling devices ($ 31.5(c)(15))
The proposed rule would add a provision that limits the amount of time a general licensee can keep a device ~ unused and would eliminate the requirement for leak testing and shutter testing while a device is in storage. ,
Cost imoacts:
There are potential cost impacts to general licensees in limiting the length of time they can store devices, but these are highly uncertain and difficult to quantify. The vast majority of
. general licensees have devices in storage because they are no longer in use due to i replacement of such devices. Almost all devices that would be in storage for as long as 2 years are destined for disposal; however, many in storage less than 2 years are put back into service.
Licensees are storing devices to avoid disposal costs; however, disposal costs are inevitable.
The actual difference in cost for any particular general licensee will depend on actual discount rates and the change in disposal costs between the time this provision leads to disposal and when it might have been disposed of absent this provision, whether there is significant decay of
- the radioactivity in that time, what arrangement the general licensee has wah the distributor for retuming the device, and the annual costs of keeping the device. For registered devices, the annual costs of keeping the device could include the registration fees which would be imposed by this rule.-
- There would be a cost savings for general licensees with the provision of 6 31.5(c)(15) to allow testing to be deferred during storage. These cost savings would result from no longer requiring the performance of leak tests and shutter tests during storage and are estimated in Section 5 on benefits.'
No significant effect on inspection and enforcement is anticipated. -
D. Transfers of Devices: Certain measuring, gauging or controlling devices
. (Revision to i 31.5(c)(8)) . l The proposed rule would add a provision to allow transfers to specific licensees other than I
- Part 32 and Agreement State licensees. This would add waste collectors specifically licensed under Part 30 or comparable Agreement State regulations. It would also allow transfers to other specific licensees but only with prior written NRC approval. Also, it would add the recipient's license number, the serial number of the device, and the date of transfer to the ;
information required to be provided to NRC upon a transfer of a device.- l This would provide some flexibility to licensees. The addition of the license number to the . j reporting requirement increases assurance that the general licensee will transfer devices only i
9 i l
to appropriate recipients. The addition of the serial number of the device will allow tracking of the individual device. The date of transfer will make the transfer easier to track and help to ensure that the general licensee makes the report in a timely way (required within 30 days).
Cost Imoacts:
No anticipated costs to licensees since this proposed rule provides for an alternative method of transfer which avoids licensees having to request exemptions to regulations. Currently, licensees must transfer devices only to Part 32 licensees so they must verify that the recipient is a Part 32 licensee. The additional information in the report will have no significant impact.
Assumptions:
Cost to NRC:
Number of requests for approval per year: 100 Staff hours per submittal: 0.5 hr Professional staff hourly rate: S70/hr Total cost per year: $3,500 No significant effect on inspection and enforcement is anticipated.
E. Notification Requirements: Certain measuring, gauging or controlling devices (9 31.5(c)(14))
The proposed rule would contain a provision that general licensees notify NRC in the event of a change of address. This applies to all 6 31.5 general licensees, because it is important for NRC to keep track of all general licensees so that they can be contacted whenever the need arises and inspected.
Cost Imoacts:
Assumptions:
General Licensees:
Number changing address per year: 100 Time spent: 0.10 Technical Staff hourly rate $50/hr Totallicensee cost per year: $500 NRC (recordina information):
Number changing address per year: 100 Staff hrs per submittal: 0.10 hrs Staff hourly rate: S70/hr Total NRC cost per year: $700 Total cost per year: *
$1,200 10
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i No significant effect on inspection and enforcement is anticipated.
F. Decommissioning Requirements: Certain measuring, gauging or controlling devices (Revision to $ 31.5(c)(5))
The proposed rule would add, to the information that must be sent to NRC in the case of ,
detection of 0.005 microcurie or more removable radioactive material or failure of or damage to i
' a source likely to result in contamination of the premises or the environs, a plan for ensuring l that premises and environs are suitable for unrestricted access. It would also change addressee / address from appropriate Regional Administrator to Director, NMSS. It would also I be noted that the criteria in 9 20.1402 may be applied by the Commission under such ,
circumstances. 1 If contamination occurs at a facility, unrestricted areas must be cleaned up to a point where public health and safety is ensured. General licensees may not have adequate knowledge to evaluate the extent of decontamination activities needed due to a leaking or damaged source.
The NRC needs to evaluate, on a case-by-case basis, a decontamination plan to ensure facilities are suitable for unrestricted use. Generallicensee's submittals of information pertaining to cleanup of facilities will s!Iow the NRC to carry out its mission. The intent is to provide additional assurance of the adequacy of decontamination of facilitics for general licensees.
The change to addressee will make all references to addressees in 31.5 the same and eliminate the need to refer to Part 20 in this regard. The addressee / address for registration will ;
be specified in the request for registration. The note concerning Q 20.1402 is for clarification. !
Cost imoacts:
Assumptions:
. General Licensees:
Number reporting (one-third of total number reporting under 6 31.5(c)(5) per year): 7 Time spent: 8 hrs Technical staff hourly rate $50/hr Totallicensee cost per year: $2,800 NRC:
Number reporting: 7 Staff hrs per submittal: 2 hrs Staff hourly rate: $70/hr Total NRC cost per year: $980 Total cost per year: $3,780 This is only the cost of reviewing this additional submittal of information from the general license:. additional effort may be involved in resolving the contamination problem. However, this is not an impact of this revision. In fact, having the general licensee include this additional 11 I
t u
information may reduce the overall cost of intervention for incidents of this type. The change in addressee / address will simplify reporting requirements for the general licensees.
No significant effect on inspection and enforcement is anticipated.
G. Reports of Transfer to another general licensee at same premises (Revision to 6 31.5(c)(9))
This revision would replace the name or position of a contact with the name and phone number of the transferee's responsible person,in reports of transfer to another generallicensee at the same location; it would also add the serial number of the device. A clarifying change is also made in paragraph (c)(9)(ii).
. This would provide a more appropriate contact to the NRC in this instance; the serial number would make tracking of individual devices easier.
Cost Imoacts:
No anticipated costs to general licensees.. This is a minor. revision to a reporting requirement which is applicable under very limited circumstances.
No significant effect on inspection and enforcement is anticipated.
H. Revision of Applicability of General License (Revision to 3 31.5(b))
The applicability of the general license to those who come into possession by an unauthorized means would be clarified such that they would not be considered general licensees.. In the case of an unauthorized transfer, the recipient would be possessing the device without a license. Also, the restriction on devices distributed under a license issued by an Agreement State that does not authorize the use of such devices within its State, would be removed.
Cost Imoacts:
This would have no impact on authorized users, but would clarify enforcement issues with respect to unauthorized users and those who inadvertently come into possession of a generally licensed device. This should somewhat simplify enforcement actions involving unauthorized recipients on the part of NRC.
The second change would be consistent with current administrative practice and so would have no cost impact.
- 1. Bankruptcy: Terms and conditions of licenses (Revision to 9 30.34(h))
The applicability of 30.34(h) on bankruptcy notification to general licensees needs to be clarified. This proposed rule would make this requirement applicable only to those general licensees subject to the registration requirement.
12
v e Cost imoacts:
None anticipated. These generallicensees are currently subject to 9 30.34(h); however, this is not clear because of the lack of a reference in 31.2.
No significant effect on inspection and enforcement is anticipated.
J. Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses (Revision to 9170.31) l The proposed rule would require a Part 170 registration fee to be submitted in conjunction with the annual registration process. Fees are proposed to be required in order to recover the cost of the general license program associated with this category of generallicense in an equitable way; that is, from those who are allowed to use devices under the general license rather that from others who hold specific licenses. NRC is required by law to recover approximately 100%
of costs from licensees' fees.
Cost Imoacts:
Assumptions:
General Licenseej:
Numberof registrants: 6000 4 Registration fee: $370 Totallicensee cost per year: $2,220,000 The cost being recovered from the general licensees is not limited to those for implementing these revisions to the general license program; instead, the cost to general licensees consists of the cost of that fraction of the overall generallicense program associated with the devices subject to the registration requirement. Since the requirement for full cost recovery was enacted, all costs of the general license program have been recovered from specific licensees.
These cost estimates include an estimate of increased inspection and follow up efforts expected to be made as a result of the registration process identifying noncompliance with existing regulations. That cost will now be passed on to the general licensees associated with the registration requirement. It is also expected that this cost will decline after the initial years of implementation of the registration process.
NRC (for collection of fees and associated followup):
Total NRC cost per year: $100,000 Total cost per year: $2,320,000 13 1
K. Impact to General Licensees in Agreement States due to Compatibility Requirements for 9 31.5 This rule would make all of 9 31.5 a Category C level of compatibility. Many of the Agreement States already have similar or identical provisions in their regulations to the existing 9 31.5.
Regulations that differ are generally more stringent, e.g., a few jurisdictions require a specific
' license for these types of devices. The most significant impact to Agreement State general licensees would be the change of the registration requirement, proposed in Rule 1, from Category D to Category C. The impact to Agreement State general licensees will depend on the approach used to achieve a Category C compatibility. Some States have already instituted a registration requirement or some other type of enhanced oversight prograrn. The largest cost to NRC general licensees under this rule would be the payment of fees. This provision would be Category D,'no compatibility required.
4.2 Requirements for Manufacturers and initial Distributors of Devices The proposed regulation would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally licensed devices.
These cost estimates include costs to distributors in Agreement States under compatible
. Agreement State regulations. These provisions would be a compatibility Category B.
A. Quarterly. Reports: Material transfer reports and records ($ 32.52(a) and (b))
The proposed rule would add the following information to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the date of transfer; indication if device is a replacement, and if so, the type, model number (Agreement States already_ require the model number), and serial number of the one retumed; name and license
' number of reporting company, and the specific reporting period; the name and phone number of the person des.ignated by the general licensee to be responsible for the device and through whom compliance with regulations will be ensured (which will replace that of a simple contact -
between the Commission and the general licensee). The address of the general licensee would be specified as the mailing address for the location of use. Also, a form will be provided for use in making these reports; however, the use of the form would not be required as long as the report is clear and legible and includes all of the required information. Revisions would be
'made to 9 32.52(a) and (b).
This provision would provide a mechanism for tracking of individual devices. It would also clarify that the contact name to be obtained from the general licensee (and reported to NRC
- and the~ Agreement State regulatory bodies) is that of the responsible individual who is to be knowledgeable of the regulations and have the authority to act for the generallicensee to
' achieve compliance with the regulations regarding generally licensed devices. The provision
. should improve NRC's ability to contact the appropriate person and to provide information to those actually knowledgeable of the device and the requirements for possession, improving general licensees knowledge of the regulations and thus their compliance with the regulations.
14
Cost imoacts:
Most of the additional information that would be provided under this proposed rule is information that vendors currently track and maintain records on. However, additional time may need to be spent to keep track of replacement devices.
Assumptions:
Distributer (NRC and Aareement State) reports to NRC:
Number of submittals per year: 356
((28 NRC+61 AS) licensees x 4 reports /yr)
Additional time spent: 0.2 hr Technical staff hourly rate $50/hr J Totallicensee cost per year: $3,560 '
NRC (recordina information): ,
Number of submittals per year: 356 Staff hrs per submittal: 0.1 hrs Staff hourly rate: $70/hr Total NRC cost per year: $2,492 Distributor (NRC and Aareement State) reoorts to Aareement States:
Number of submittals: 1780 (assuming an average of 5 States per distributor)
Staff brs per submittal: 0.1 brs Staff hourly rate: $50/hr Total cost per year for reports to States: $8,900 Total cost per year: $14,952 No significant effect on inspection and enforcement is anticipated.
B. Retention: Material transfer reports and records ($ 32.52(c))
The proposed rule alters the records retention so that records of transfers would have the period of retention extended from 5 years after a recorded event to 3 years after the expected useful life of the device or the final disposition, if known. The proposed rule also adds a requirement for records on final disposition of devices.
This improves the ability to track individual devices. Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the generallicense regulatory program.
Cost Imoacts:
This section of the proposed rule would create small incremental costs (i.e. <$1,000) for licensees as a result of the increase in the length of the records retention period and rnecrding of the final disposition of devices. Most manufacturers record this information on a database 15
- e and currently retain this information indefinitely. In addition, the time spent for data entry into a database for recording final disposition of devices is small making the corresponding costs small.
- No significant effect on inspection and enforcement is anticipated.
C. Recordsi Conditions of licenses ($ 32.51a(d))
The proposed rule would add a requirement for the distributors to provide upon request to the
- NRC and Agreement States,' records of final disposition of devices in the case of bankruptcy or termination of license.' This information must be available upon request.
This will assist the NRC and the Agreement State agencies in tracking individual devices.
Further, these revisions will better enable the NRC to verify the location, and disposition of these devices, and thereby confirm the efficacy of the general license regulatory program.
Cost imoacts:
This section of the proposed rule would create smak incremental costs (i.e. <$1,000) for licensees as a result of making available to various regulatory agencies records of final disposition of devices in the case of bankruptcy or termination of license.- Most manufacturers record this information on a database. Therefore, the time spent to transfer this information to regulatory agencies is small.'. The number of manufacturers going bankrupt or requesting license termination is small, making the corresponding costs small. In addition, this information only needs to be provided upon request making the number of times the information needs to be provided even smaller.
No significant effect on inspection and enforcement is anticipated.
D. . Labeling: Byproduct material contained in devices for use under 6 31.5; requirements for license to manufacture, or initially transfer ($ 32.51(a)(4) and (5) and $ 32.51a(c))
~
The proposed rule would revise 6 32.51(a)(4) and (5) and f 32.51a(c) to add requirements for a label on any separable source housing, and a permanent label on devices meeting the criteria for registration.
The first of these changes is simply an extension of the existing requirement and carries out the initial intent of the current regulations in the case of devices where the source may be separable in a housing that does not include the label. It is important that this housing, if separated from the remainder of the device, can also be identified. Labels are approved by the NRC as part of the licensing process. Labels are generally put on separable housings under -
present practice; however, this should be clearly required. Also, many existing labels would already meet the " permanent" requirement.
' This part of the proposed rule would increase the likelihood that devices, including any separable source housings, include labels that stay intact even in non-routine circumstances
- (such as theft, loss, damage), and as 'a result, would increase the likelihood that the device i
16 L
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F r o intact generally licensed device. However, when a device has been damaged, the material in the device may no longer be fully contained within the device, i.e., it may also be unsealed radioactive material. Action can be taken by the NRC under f 30.61, " Modification and revocation of licenses," which is applicable to general licensees. The provision proposed in this action would require that the general licensee propose to the Commission how it will be shown that the premises are or will be adequately cleaned up. Depending on the nature of the event, the remedial action taken (and reported under existing requirements) along with any confirms. tory surveys may be sufficient to complete action on the event.
The addressee for submitting information under 6 31.5(c)(5) would be changed from Regional Administrator to Director of Nuclear Material Safety and Safeguards so that all NRC addressees specified in f 31.5 for reports by these licensees are the same and to eliminate the need for the general licensee to refer to part 20 to determine the appropriate addressee. The I l
addressee and address for registration will be specified in the registration request. Adding a '
note concerning the possible applicability of f 20.1402 is a clarification.
(6) Revision to f 31.5(9)(i) - Reporting new general licensee's responsible individual.
I
. Consistent with the provision for appointing an individual through whom the general licensee will ensure compliance with the applicable regulations and requirements, and other reporting requirements being proposed, it is more effective for the general licensee to provide the name of the new responsible individual when another general licensee takes over the facility and !
res. pons'ibility for the device.
l An additional' proposed amendment to f 31.5 would clarify the status of a person who l receives a device through an unauthorized transfer and would remove a restriction on devices.
Paragraph (b) would be revised to (1) limit the applicability'of the general license to those who
]
' receive a device through an authorized transfer and (2) expand the applicability of the general i
i 15
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e
L license to devices authorized for distribution by an Agreement State who has no general license covering the use of such devices within that State.
L Concerning the first of these issues, the NRC has generally, although not consistently, L interpreted the general license to apply to any recipient within the group identified in 31.5(a),
i.e., ".. commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and Federal, State or local government agencies.." ,
even if the device is received through an unauthorized transfer. The proposed language would clearly provide that the general license does not apply if the device is obtained through an unauthorized transfer. In the case of an unauthorized transfer, the recipient would possess the device without a license.
~ Paragraph 31.5(b) currently restricts applicability in the case of devices from distributors in Agreement States to those from States who authorize the devices to be used under a general license within their respective States. To accommodate the occasional distributor in an Agreement State that has no comparable general license, NRC's administrative practice has been to allow the Agreement State to issue specific licenses equivalent to 6 32.51 licenses.
, The'NRC has allowed the use of devices authorized by these States by 6 31.5 general licensees. This approach reserved for NRC the right to require distributors in this situation to
- obtain an NRC distribution license in order to transfer devices into NRC jurisdiction, but did not require them to do so as long as the State issued acceptably equivalent licenses. Through NRC's oversight of Agreement State programs, NRC ensures the safety of these devices.
Given this fact and the experience to date with these few States, the Commission believes that this restriction is no longer necessary.
In addition to the proposed changes to f 31.5, other amendments are proposed that would clarify which sections of the regulations in part 30 apply to all of the general licensees 16 i
L_l . - - _ ' _ .-- _ _ _ - - _ _ _ _ _ - . _
4 E i
l under part 31. Section 31.1, " Purpose and scope," would be amended to clarify that only those paragraphs in pan 30 specified in 31.2 or the particular general license apply to part 31 generallicensees. Section 31.2," Terms and conditions," would be amended to reference the sections of part 30 that are applicable to all of the part 31 general licensees, including Q 30.7,
" Employee protection," 30.9, " Completeness and accuracy of information," and Q 30.10,
" Deliberate misconduct." The proposed clarification would make it easier for general licensees to be aware of applicable regulations. In addition, future amendments to part 30 that would apply to part 31 general licensees would include a conforming amendment to part 31. Note, however, that while S 31.2 would specify sections of part 30 generally applicable to general licenses, it would not eliminate the applicability of other parts of the Commission's regulations that may apply.
The applicability of 9 30.34(h) on bankruptcy notification to general licensees also needs to be clarified. Under the existing regulations, this requirement appears to apply to all licensees. However, its application to general licensees is not clear because it is not referenced in f 31.2 or 6 31.5. This proposed rule would make the bankruptcy notification requirement applicable only to those general licensees subject to the registration requirement.
These licensees possess devices for which the Commission believes a higher level of oversight is appropriate. Thus, notification that such a general licensee is filing for bankrup*cy may be important to allow the Commission to intervene to ensure that the financial status of the licensee does not lead to the improper disposal or abandonment of a device.
Requirements for Manufacturers and initial Distributors of Devices. The proposed rule would modify the quarterly transfer reporting, recordkeeping, and labeling requirements for
. spacific licensees who distribute these generally licensed devices, and the requirement for 17
providing information to users. The existing requirements in these areas are a matter of strict compatibility of Agreement State regulation, that is, the State regulations are essentially
- identical. .The proposed amendments would also be a matter of strict compatibility so that revisions to A' greement State regulations would be necessary and distributors in Agreement
- States would be affected. The basis of this compatibility requirement is significant direct
.transboundary irnplications. This results from the fact that devices are distributed under various Agreement State and NRC authorities into other jurisdictions where ufferent regulatory n
- agencies regulate the possession and use of the devices. Currently, there are 28 NRC licensed distributors and approxima:ely 61 licensed distributors in Agreement States.
Rooortina. The following information would be added to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the date of transfer; .
indication if device is a replacement, and if so, the type, model number, and serial number of the one retumed; name and license number of reporting company; and the specific reporting period. The model' number of the device is already required in reports to Agreement States.
l The' general licensee address would be specified as the mailing address for the location of use of the generally licensed device.
The name and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements would replace the name and/or position of a simple contact between the Commission and the general licensee.
A form will be provided for use in making these reports. However, the use of the form would not be required as long as the report is clear and legible and includes all of the requir(c information. Proposed amendments would be made to 9 32.52(a) and (b).
18 e \
1 4 r j l
I The existing reporting requirement is intended to provide NRC and the Agreement State I regulatory agencies with the identity of general licensees in their jurisdictions, addresses at l
which tha generallicensees can be contacted (which are usually the location of use of the )
devices), the particulars of the type of device possessed, and the name (or position) of an individual who constitutes a point of contact between the NRC or the Agreement State and the l
generallicensee. These generallicensees can then be contacted or inspected. Including the serial number would allow the NRC and Agreement States to track individual devices. The ,
i existing reporting requirement in $ 31.5(c)(8) does not require the general licensee to report a transfer if it is for the purpose of obtaining a replacement. This is consistent with the original intent of this regulation in that the status of the general licensee is unchanged, only the specific device is changed. In order for individual devices to be tracked, the NRC or Agreement State needs to be informed of such a transfer. The proposed rule would require that the distributor provide this information either to NRC or the appropriate Agreern nt State. Under existing requirements, quarterly reports are required to include specifics on any new device transferred but not on the devices retumed. The NRC believes that the distributor could include this additional information in the quarterly reports without a significant burden and that the distributor is likely to be more reliable than the general licensee in providing this information.
The name and license number of the reporting company and the specific reporting period are typically included in the reports in order to show compliance with the reporting requirement.
However, this information is not always readily identifiable.
The individual who acts as contact with the NRC or the Agreement State concerning the general license should have knowledge of the device, the general license, and the regulations pertaining to the general license, or at least know who in the organization does. This is the intent of the existing requirement. However, in practice, the name given to the distributor and 19
reported to the NRC (or the Agreement State) frequently is not an individual with this type of knowledge. The proposed rule would specify that the contact designated be the person
'(1) assigned responsibility for ensuring that the general licensee is aware of its regulatory responsibilities and (2)'who has authority to take required actions for complying with the applicable regulations.
Recordkeepina. The proposed rule would add to the recordkeeping requirements information on final disposition of devices. The recordkeeping requirements conceming transfers would have the period of retention extended from 5 years from the date of the recorded event, to 3 years after the expected useful life of the device or the final disposition, if known. Proposed amendments would be made to 6 32.52(c).
. It is important that information about the general licensees and the specific devices in their possession be available until the device is disposed of permanently. Requiring the distributor to keep these records for an extended time provides a backup to the recordkeeping of NRC and plate regulatory agencies. The records include information on final distribution that may not have been included in reports to NRC and the Agreement States. It is NRC's understaking that these ' distributors generally keep these records indefinitely. Thus, this regulatory requirement should have little, if any, impact.
In addition, distributors would be required to make available records of final disposition of devices to the various regulatory agencies in the case of bankruptcy or termination of license '
. (new paragraph 9 32.51a(d)). When a distributor goes out of business and terminates its
- license, the distributor can no longer be required to retain these records. This requirement would give NRC, as well as State regulatory agencies, the opportunity to obtain and retain records of this type previously kept by the distributor. These records could be helpful in verifying information used to keep track of devices relative to the final disposition of devices.
20 L _ . _ . _
4 0 This provision would not require distributors to automatically provide these records unless the NRC or the Agreement State in which the device was distributed makes a request for these
- records. In the case of bankruptcy, NRC or the Agreement State may want to secure these records early in the process, in case financial difficulties interfere with the licensee fulfilling its responsibilities.
Labelina. The proposed rule would amend the existing labeling requirements to require an additional label on any separable source housing and a permanent label on devices meeting the criteria for registration (new paragraphs 32.51(a)(4) and (5) and 9 32.51a(c)). The NRC
. would consider a label " permanent," if, for example, it were embossed, etched, stamped, or engraved in metal. Under these requirements, new distribytors would have labels approved as l part of obtaining a license; distributors including existing licensees would have the new labeling requirements as conditions of license in 32.51(a)(4) and (5). Approval of the new labels by l NRO for existing distributors would not be required. However, distributors may voluntarily 1
submit information for NRC review on how they plan to comply with the new labeling i requirements. In any case, labeling is subject to inspection. To the extent necessary, the new i labeling requirements would supercede anything contradictory in individual license conditions.
The individual license conditions would be updated to include specifics related to the new requirements during the first license renewal or amendment following the effective date of those paragraphs of the rule.
l The first change simply carries out the initial intent of the existing requirement for devices where the source may be separable in a housing that does not include the label. It is important that this housing, if separated from the remainder of the device, can also be identified. The impact of this requirement should be minimal. The permanent label for devices requiring registration would provide better assurance that even when a device has been 21 i
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[
q.
F exposed to other than normal use conditions, for example, when a building has been
' refurbished or demolished with the device in place, the label will be intact and the device may
- be identified and proper actions can be taken. This may result in a more significant change to the production of devices. Distributors would have 1 year after the effective date of the rule to implement these changes to minimize any impact to the manufacturing and distributing process.
~ Information to be provided to aeneral licensees. The proposed rule would amend the requirements pertaining to the information distributors must provide to the general licensee
-($ 32.51a(a) and (b)). Distributors are now required to provide general licensees with a copy of
_ $ 31.5 when the device is transferred. The proposed rule would require that a copy of 6 31.5 be provided before kansfer. The distributor would also be required to provide copies of additional applicable sections.of the regulations,' a listing of the services that can only be performed by a specific licensee, and information regarding disposal options for the devices being transferred. The disposal options would include the estimated cost for disposal of the Cevice at the end of its useful life to the extent that the cost information is available to the distributor at the time of the sale of the device. For transfers to general licensees in Agreement
' States, the distributor may fumish either the applicable NRC regulations or the comparable
- ones of the Agreement State. In addition, the distributor would furnish the name, address, and
' phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.
- The general licensee should be aware of the specific requirements before purchasing a l generally licensed device, rather than afterward. While the Commission does not want to get involved with details of licensees' business practices, it is the Commission's intent that " prior to 22-
, t
s a transfer" would be before a final decision to purchase so that the information can be considered in making that decision.
While @ 31.5 contains the primary requirements related to the general license, it does not reference the applicable sections of part 30. The generallicensee should have copies of at least those regulations that may require an action on his part. The sections of the regulation that would be included in this requirement are believed to be the most important for the general licensee to be aware of. The inclusion of a listing of services that can only be performed by a specific licensee would clarify the services that can and cannot be performed by the general I
licensee. These services vary depending on the nature and design of the particular device and so are not specified in the regulations. Information on the estimated cost for disposal of the l
device at the end of its useful life may be a significant factor in a decision to purchase a device j because of the high costs of disposing of radioactive materials. In some cases, the cost of disposal could exceed the purchase price of the device.
Additional clarifying amendments would be made in @ 30.31, 30.34(h), and 31.5(c)(9)(ii). The wording of 9 30.31 would provide a similar clarification as that in the Suggested State Regulations with respect to generallicenses. The amendment to Q 30.34(h) would be consistent with the previously discussed change concerning reporting bankruptcy.
The revision of 31.5(c)(9)(ii) to include the term, " intermediate person," is intended to provide clarification about intermediate persons holding devices. Specifically, intermediate l
persons holding devices in their original shipping containers at their intended location of use are i generallicensees. Distributors licensed under 9 32.51, or equivalent Agreement State !
I regulations, must provide information about both intermediate persons and intended users in their quarterly reports submitted under 32.52(a). Transfers from intermediate persons to 23 i
I
'b intended users under 6 31.5(c)(9)(ii) do not need to be reported to NRC because information
- about the intended user must be reported by the distributor under 32.52(a).
- l Minor conforming amendments would also be made to 66170.2,170.3,171.5, and 171.16.
Public Comments on the Original Proposed Rule The NRC reviewed the comments received on the December 27,1991, proposed rule in
' developing both the proposed rule published on December 2,1998 (63 FR 66492), and this
' proposed rule. There were 26 comment letters received from a variety of sources including private and publicly held corporations, private c!tizens, citizens groups, the Armed Forces, and
. State govemments. These comments have been considered to the extent applicable to each rule. A detailed analysis of the comments received on the December 27,1991, proposed rule,
- which was withdrawn by the notice of proposed rulemaking on December 2,1998, is not presented in either of the subsequent proposed rules because many of the specific comments
- pertain to specific provisions that have been. withdrawn, a great deal of time has passed since
' these comments were made, and additional opportunity for comment is being provided.
' Early State and Public Input These proposed amendments were provided to the Agreement States twice during its development via the use of the NRC Technical Conference Website and notification to the States of its availability.11nput was received following the first posting through discussions at an
~ All Agreement State meeting in October of 1998. The second posting was also available to the 24 e
Q.
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public. A notice of availability was published December 31,1998 (63 FR 72216). The States and the distributors were notified of its availability directly, as well. Two comments were received. One from a State and one from industry. They were generally supportive and indicated points needing clarification.
Summary of Proposed Provisions by Paragraph 30.31 - Revision would reconcile the apparent conflict between the description of a general license and a registration requirement.
i Q 30.34(h)(1) - Revision would make the bankruptcy notification requirement applicable 1 only to those general licensees subject to the registration requirement.
@ 31.1 - Revision would clarify that only those paragraphs in part 30 specified in 9 31.2 l
or the particular general license apply to part 31 general licensees.
31.2 - Revision would clarify references to the sections of part 30 that are applicable to all of the part 31 generallicensees.
9 31.5(b) - Revision would clarify the status of a person who receives a device through an unauthorized transfer by limiting the applicability of the generallicense to those who receive i a device through an authorized transfer; and would remove the restriction on devices distributed by Agreement State licensees in Agreement States without a general license.
9 31.5(c)(5)- Revision would add a plan for ensuring that premises and environs are suitable for unrestricted access, to the information that must be sent to NRC in the case of a failure, when device damage or failure is likely to or known to have resulted in contamination; would change the addressee for reporting information concerning a failure; and would clarify that the criteria in 20.1402 may be applied in spite of the exemption in @ 31.5(c)(10).
25
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1 6 31.5(c)(8)- Revision would allow transfers to specific licensees authorized under part 30, or equivalent Agreement State regulations, as waste collectors, in addition to currently allowed transfers to part 32 (and Agreement State) licensees; would allow transfers to other specific licensees but only with prior written NRC approval; and would add the recipient's license number, the serial number of the device, and the date of transfer to the information required to be provided to NRC upon transfer of a device.
- $ 31.5(9)(i)'- Revision would add to the reporting requirement, in the case of a transfer to a general licensee taking over possession of a device at the same location, to provide the serial number of the device and the name and phone number of the person identified as having knowledge of and authority to take required actions to enspre compliance with the appropriate l regulations and requirements, rather than simply a contact name.
l 9 31.5(9)(ii) - Revision would add the term, " intermediate person," to clarify tht a Mport
- of transfer is not required only when the information on both an intermediate person se an !
- intended user was provided through the distributor in a quarterly material transfer report.
9 31.5(c)(12) - Would add an explicit requirement for the general licensee to appoint an individual assigned responsibility for knowing what regulatory requirements are applicable to the general licensee and having authority to take required actions to comply with the applicable regulations.
$ 31.5(c)(13) - Would add an explicit requirement for the general licensee to register
~ devices meeting certain criteria, which specifies the information to be'provided and references
. the fee requirement in G 170.31.
9 31.5(c)(14) - Would add requirement for general licensees to notify NRC of address changes.-
26
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.% 31.5(c)(15) - Would limit the amount of time a general licensee can keep an unused device in storage and allow the deferment of testing during the period of storage.
9 32.51(a)(4) and (5) - Would add requirement for an additional label on any separable source housing and a permanent label on devices meeting the critoria for registration.
L 9 32.51a(a) and (b) '- Revision would amend the requirements pertaining to the
)
information distributors must provide to the general licensee. Distributors are now required to i
provide general licensees with a copy of 9 31.5 when the device is transferred. The proposed rule would require that f 31.5 be provided before transfer. The distributor would also be required to provide copies of additional applicable sections of the regulations, a listing of the services that can only be performed by a specific licensee,.and information regarding disposal options for the devices being transferred, including estimated costs of disposal. For transferr to general licensees in Agreement States, the distributor may furnish either the applicable NRC regulation's or ti. 4 comparable ones of the Agreement State. In addition, the distributor would
.. furnish the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.
6 32.51a(c) - Would make labeling requirements a condition of license 1 year after
~ effective date of rule.-
6 32.51a(d) Would add requirement for distributors to make available records of final
- disposition of devices to the various regulatory agencies in the case of bankruptcy or termination of the distributor's license.
$ 32.52(a) and (b) - Revision would add the following information to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the
-date of transfer; indication.if device is a replacement, and if so, the type, model number, and serial number of the one retumed; name and license number of reporting company; and the 27
. .l_
specific reporting period. Also, the general licensee address would be specified as the mailing address for the location of use of the generally licensed device.
The name and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements would replace the name and/or position of a simple contact between the Commission and the general licensee. Also, a form will be provided for use in making these reports. However, the use of the form would not be required as long as the report is clear and legible and includes all of the required information.
32.52(c) - Revision would add to the recordkeeping requirements information on final disposition of devices. The recordkeeping requirements concerning transfers would have the period of retention extended from 5 years from the date of the recorded event to 3 years after the expected useful life of the device or the final disposition, if known.
170.2 - Would conform scope to include a general licensee registrant.
9170.3 - Would revise definition of " Materials License" to include part 31 and the words, "or granted" as general licenses are granted by regulation rather than individually issued to licensees.
Q 170.31 - Revision would add $370 registration fee for general licensees subject to 6 31.5(c)(13).
6171.5 - Would revise definition of " Materials License" to include part 31 and the words, "or granted" as general licenses are granted by regulation rather than individually issued to licensees.
@ 171.16 - Would add category for part 31 general license registration for consistency with the Table in 170.31.
28
Enforcement 1
On March 9,1999 (64 FR 11508), the Commission established an interim enforcement policy for violations of o 31.5 that licensees discover and report during the initial cycle of the registration program. This policy supplements the normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one complete cycle of the registration program.
Under this interim enforcement policy, enforcement action normally will not be taken for violations of 31.5 that are identified by the general licensee, and reported to the NRC if reporting is required, provided that the general licensee takes appropriate corrective action to address the specific violations and prevent recurrence of similar problems and otherwise has undertaken good faith efforts to respond to NRC notices and provide requested information.
This change from the Commission's normal enforcement policy is to remove the potential for the threat of enforcement action to be a disincentive for the licensee to identify deficiencies.
This approach is warranted given the limited NRC inspections of general licensees. This approach is intended to encourage generallicensees to determine if applicable requirements have been met, to search their facilities to ensure sources are located, and to develop appropriate corrective action when deficiencies are found. Under the interim enforcement policy, enforcement action, including issuance of civil penalties and Orders, may be taken where there is: (a) failure to take appropriate corrective action to prevent recurrence of similar violations; (b) failure to respond and provide the information required by regulation; (c) willful failure to provide complete and accurate information to the NRC; or (d) other willful violations, such as willfully disposing of generally licensed material in an unauthorized manner.
I i
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t As noted in the December 2,1998, proposad rule, the Commission also plans to increase the civil penalty amounts specified in its Enforcement Policy in N'UREG-1600, Rev.1, for violations involving lost or improperly disposed sources or devices. This increase will better
-relate the civil penalty amount to the costs avoided by the failure to properly dispose of the sou'r ce or device. .. Due to the diversity of the types of sources and devices, the Commission is considering the establishment of three levels of base civil penalty for loss or improper disposal.
The three levels of base civil penalty would be $5500, $15,000, and $45,000. The higher tiers would be for sources that are relatively costly to dispose of and would be based on approximately three times the average cost of proper transfer or disposal of the source or device.
Agreement State Compatibility Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" published on September 3,1997 (62 FR 46517), the proposed rule would be a matter of compatibility between the NRC and the Agreement States, thereby providing !
- consistency among Agreement State and NRC requirements. The revisions to part 32 would be classified as Category B and the revisions to 9 31.5 would be classified as Category C.
- - Through this action, existing provisions of $ 31.5 would also be reclassified from Category D to
- Category C. Although changes are being made to 99 30.31,30.34(h)(1),31.1, and 31.2, and parts .170 and 171 as part of this rulemaking, the existing compatibility designations for these 1 regulations will not be affected.
- Category B'means the provisions affect a program element with significant direct transboundary implications. The State prog;4m element should be essentially identical to that 30 E.. l
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of NRC. Category C means the provisions affect a program element, the essential objectives of I
which should be adopted by the State to avoid conflicts, duplications, or gaps in the national program. The manner in which the essential objectives are addressed need not be the same as NRC provided the essential objectives are met.
Specific information about the compatibility or health and safety components assigned to this rule may be found at Office of State Programs website, http //www.hsrd.ornl. gov /nrc/home.html.
As discussed above, revised @ 32.52(a) and (b) would add the following information to the existing distributor's quarterly transfer reporting requirements: the serial number and model number of the device, the date of transfer, indication if the . device is a replacement (and if so, the type, model number, and serial number of the device returned), the name and license number of the reporting company, and the specific reporting period. The proposed revisions would also require the name and phone number of a generallicensee's " responsible individual" rather than simply a contact and would specify that the address of the general licensee be the mailing address for the location of use. According to NRC Management Directive (MD) 5.9,
" Adequacy and Compatibility of Agreement State Programs," NRC regulations that should be adopted by an Agreement State for purposes of compatibility should be adopted in a time frame such that the effective date of the State requirement is no later than 3 years after the effective date of NRC's final rule. MD 5.9 also provides that some circumstances may warrant that the States adopt certain regulations in less than the recommended 3-year time frame or that the effective dates for both NRC licensees and Agreement State licensees be the same. The Commission believes it is important to the implementation of this program, and to Agreement State programs, to begin receiving the additionalinformation in the distributors' quartarly transfer reports as soon as possible. The Commission requests comments on whether NRC 31
and the Agreement States should establish a single implementation date for this provision which would be earlier than is usually allowed for revision of Agreement State rules for compatibility. One approach would be to request Agreement States to require distributors to
' provide all the information consistent with this rule (proposed $ 32.52(a) and (b)) either coincident with the effective date of the Commission's final action on this rulemaking or within
- 1 year of that effective date.' Agreement States would have the flexibility to adopt this provision through rulemaking, license conditions, or other legally binding requirements.
Plain Language The Presidential Memorandum dated June 1,1998, entitled, " Plain Language in
~ Govemment Writing," directed that the government's writing be in plain language. This memorandum was published June 10,1998 (63 FR 31883). In complying with this directive, editorial changes have been made in the proposed revisions to improve the organization and readability bi the existing language of paragraphs being revised. These types of changes are not discussed further in this notice. The NRC requests comments on this proposed rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the heading: " ADDRESSES" ab'ove.
- Environmental Impacti Categorical Exclusion 1 The NRC has determined that the revisions proposed in this rule are the types of actions
.- deEcribed in the categorical exclusions in f 51.22(c)(1) through (3). Therefore, neither an 32
environmental impact statement nor an environmental assessment has been prepared for this regulation.
Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This rule has been submitted to the Office of Management and Budget for review and approval of the information collection requirements.
The public reporting burden for this information coll.ection is estimated to average 2 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. The time involved is small because most of the proposals are minor
, revisions to existing information collection requirements. The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the information collections contained in the proposed rule and on the following issues:
- 1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether tiie information will'have practical utility?
- 2. Is the estimate of burden accurate?
- 3. Is there a way to enhance the quality, utility, and clarity of the information to be
- collected?.
4.- How can the burden of the information collection be minimized, including the use of automated collection techniques?
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Send comments on any aspect of this proposed information collection, including Tsuggestions for reducing the burden, to the Records Management Branch (T-6F33), U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at
. BJS1 @ NRC. GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202 (3150-0016), Office of Management and Budget, Washington, DC 20503.
. Comments to OMB on the information collections or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of corisideration cannot be given to comments received after this date.
Public Protection Notification if a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct 'or sponsor, and a person is not required to
- respond to, the information collection, j i
Regulatory Analysis
]
)
t The NRC has prepv9d a draft regulatory analysis for this proposed regulation. The analysis examines the cost and ceneJts of the alternatives considered by the NRC. The comments received on the draft reguwtory analysis associated with the proposed rule of December 27,1991, have been considered to the extent that they apply to this action. The
. regulatory analysis is available for inspection in the NRC Public Document Room,2120 L Street NW. (Lower Level), Washington, DC. Single copies of the analysis may be obtained by calling 34 l
l L:
Catherine R. Mattsen, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6264; or e-mail at CRM @nrc. gov.
1 Regulatory Flexibility Certification As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission has evaluated the impact of this rule on small entities. The Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The most significant cost of this proposed rule would be the fee of $370 to be assessed with the annual registration. The proposed rule would apply to the approximately 45,000 persons possessing products under an NRC general license, many of whom may be classified as small entities. However, the annual registration requirement and associated fee would apply to about 6000 of these general licensees, each paying the same $370 irrespective
- of the number of devices possessed. The NRC believes that the fees will not present a significant economic impact on these licensees and that the economic impact of the additional J proposed requirements on any general licensee e/ould be a negligible increase in administrative
' burden. Based on input received previously from small entities who hold materials licenses, the
' NRC believes that the $370 part 170 registration fee would not have a significant economic impact on a substantial number of small entities. The NRC is soliciting comment from the
- general licensees that would be required to register their devices pursuant to part 31 on
. whether the proposed part 170 fee for their annual registration would have a significant economic impact on their business.
_; 35
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p The proposed rule would also revise requirements for specifically licensed distributors of certain generally licensed devices. Currently, there are 28 NRC licensed distributors and 1
approximately 61 Agreement State licensed distributors. Many of these licensees are not small entities and the impact to any of these distributors is not expected to be significant in any case.
Distributors who are small entities are also invited to comment on whether they believe the economic impact would be significant.
Those small entities that offer comments on the potential impact on small entities and how that might be minimized should specifically include information on the type and size of their business and how the proposed regulations would result in a significant economic impact on them as compared to larger organizations in the same business community. To the extent 3 possible, the commenter should provide relevant economic data, such as the licensee's gross annual receipts, as well as number of employees.
Backfit Analysis The NRC has determined that the backfit rule,9 50.109, does not apply to this proposed rule and, there? ore, a backfit analysis is not required because these amendments would not I
involve any provisions that would impose backfits as defined in 50.109(a)(1). I I
List of Subjects 10 CFR Part 30 - Byproduct material, Criminal penalties, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
36 l
10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific eq'uipment.-
10 CFR Part 32 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
10 CFR Part 170 - Byproduct material, import and export licenses, intergovemmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
10 CFR Part 171 - Annual charges, Byproduct material, Holders of certificates,
. registrations, approvals, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
For the reasons set out above and under the authority of the Atomic Energy Act of 1954, )
l as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553, the NRC
' is proposing to adopt the following amendments to 10 CFR Parts 30,31,32,170, and 171.
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, o PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL
- 1. The authority citation for Part 30 continues to read as follows:
Authority: Secs. 81, 82,161,182,183,186, 68 Stat. 935, 948, .053, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended, (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236,2282); secs. 201 as amended,202,206,88 Stat.1242, as amended, 1244,1246 (42 U.S.C. 5841, 5842, 5846).
Sec. 30.7 also issued under Pub. L.95-601, sec.10,92 Stat. 2951 as amended by Pub.
L.102-486; sec. 2902,106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also issued under sec.184,68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec.
187,68 Stat. 955 (42 U.S.C. 2237).
- 2. Section 30.31 is revised to read as follows:
I
$ 30.31 Types of Licenses.
Licenses for byproduct material are of two types: General and specific.
(a) The Commission issues a specific license to a named person who has filed an application for the license under the provisions of this part and Parts 32-36, and 39.
. (b) A general license is provided by regulation, grants authority to a person for certain activities involving byproduct material, and is effective without the filing of an application with j the Commission or the issuance of a licensing document to a particular person. However, registration with the Commission may be required by the particular general license.
i 38
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- 3. In 9 30.34, paragraph (h)(1) is revised to read as follows:
r 9 30.34 Terms and conditions of licenses.
f ., .. . , , ,
~
._. (h)('1) Each general licensee that is required to register by $ 31.5(c)(13) of this chapter and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing,
- immediately following the filing of a voluntary or involuntary petition for bankruptcy under any -
. chapter of title 11'(Bankruptcy) of the United States Code by or against:
- (i) The licensee;-
(ii) An entity (as that term is defined in 11 U.S.C.101(14)) controlling the licensee or i
listing the license or licensee as property of the estate; or -
(iii) An affiliate (as that term is defined in 11 U.S.C.101(2)) of the licensee. )
i PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
- 4. The authority citation for Part 31 continues to read as follows:
Authority: Secs. 81,161,183,68 Stat. 935,948,954, as amended (42 U.S.C. 2111, i 2201, 2233): secs. 201, as amended, 202, 88 Stat.1242, as amended, 1244 (42 U.S.C. 5841, 5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021). I u,
i a f 39
..}-
- . i . .
g
- a. . a s s 5 Shetion 31.1 is revised to read as follows:
- $ 31.1 Purpose and scope.
. This'part establishes general licenses for.the possession and use of byproduct material
,and a general license for ownership of byproduct material. Specific provisions of 10 CFR Part 30 are applicable to general licenses established by this part. These provisions
- are specified in f 31.2 or in the particular general license.
a
. 6. Section 31.2 is revised to read as follows:
$ 31.2 Terms and conditions.
~
The general licenses provided in this part are subject to the general provisions of
. ' Part 30 of this chapter ($$ 30.1 through 30.10), the provisions of $9 30.14(d),30.34(a) to (e),
30.41,30.50 to 30.53,30.61 to 30.63, and Parts 19,20, and 21, of this chapter' unless L indicated otherwise in the specific provision of the general license.
n l-
' Attention is directed particularly to the provisions of Part 20 of this chapter concerning labeling of containers.
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RULEMAKING ISSUE (Notation Vote)
April 9.1999 SECY-99-108 FOR: The Commissioners FROM: William D. Travers Executive Director for Operations
SUBJECT:
PROPOSED RULE: 10 CFR PARTS 30,31,32,170, and 171 -
" REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" PURPOSE:
To request Commission approval of a proposed rule that would explicitly require general licensees who possess certain devices containing byproduct material to register their devices, and add other provisions that are intended to improve the accountability of generally licensed devices.
BACKGROUND:
Individuals who possess devices under the generallicense in f 31.5 are not always aware of ppplicable requirements and thus are not necessarily complying with all of these requirements.
4 l'he Commission has been most concerned about occurrences where generally licensed devices have not been handled or disposed of properly. In some cases, this has resulted in radiation exposure to the pu'o lic and contamination of property. Some generally licensed devices have been accidentally melted in steel mills causing considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust.
Although known exposures have generally not exceeded the public dose limits, there is a potential for significant exposures.
CONTACT: Catherine Mattsen, NMSS/IMNS (301) 415-6264 i) 'h () Q '
1 s e I
The Commissioners 2 in July 1995, with assistance from the Organization of Agreement States, NRC formed a working group to evaluate the issues related to the loss of control of generally and specifically licensed sources of radioactivity. This NRC/ Agreement State Working Group submitted a final l report to NRC concerning its evaluation. On October 18,1996, the staff provided its evaluation I of the working group recommendations in SECY-96-221. This report was published as NUREG-1551 in October 1996. On November 13,1996, the staff briefed the Commission on I its preliminary views of the NRC/ Agreement State Working Group's recommendations. ;
in an April 13,1998, Staff Requirements Memorandum (SRM), responding to SECY-97-273,
" Improving NRC's Control Over and Licensees' Accountability for Generally and Specifically i Licensed Devices,"(Attachment 1) the Commission directed the staff to terminate the 1991 rulemaking except fct the provisions that would enable NRC to request information from certain l general licensees to provide the regulatory basis for a registration program and to renotice '
those portions of the 1991 proposed rule for public comment. That proposed rule notice was provided to the Commission in SECY-98-199, approved by an SRM of October 23,1998, and published on December 2,1998 (63 FR 66492). The April 13,1998, SRM also directed the staff to develop, in a subsequent rulemaking, a registration and follow-up program for generally licensed sources / devices identified by the NRC/ Agreement State Working Group in NUREG-1551, to assess fees to these general licensees, and to incorporate req'uirements for the permanent labeling of sources / devices. The staff was also directed: (a) to explore the possibilities, advantages, and disadvantages of various fee approaches such as pro-rating the fees, e.g., per device (fixed or sliding scale) or per license, and provide recommendations to the Commission; and (b) to determine the extent to which application of the small business rule will affect the fees. The analysis of fee options (Attachment 2) and this proposed rule (Attachment 3) respond to those directives (Item 3 of the SRM).
In the April 13,1998, SRM (Item 6), the Commission also directed the staff to implement an enforcement program that includes a short amnesty program and increased civil penalties for both general and specific licensees for " lost" sources. The inte:im enforcement policy addressing the amnesty was presented to the Commission in SECY-98-303 and published March 9,1999 (64 FR 11508). The Commission indicated that the increased civil penalties should be significantly greater than the costs of proper disposal or transfer of a source or device. The NRC/ Agreement State Working Group recommended civil penalties in the range of 2 to 3 times the cost of authorized disposal. Due to the diversity of. types of sources and devices, the staff is considering the establishment of three levels of base civil penalty for lost sources. The three levels would be $5,500, $15,000, and $45,000. The base civil penalty could be adjusted by the civil penalty adjustment factors in the current Enforcement Policy. In addition, in accordance with Section Vll.A.1(g) of the current Enforcement Policy, enforcement discretion could be used to increase the civil penalty amount or to assess a civil penalty where application of the adjustment factors normally would result in zero civil penalty. Under the current Enforcement Policy, the base civil penalty at Severity Level I for a general license is
$5,500. The two higher tiers would be for sources that are relatively costly to dispose of and are based on 3 times the average cost of proper transfer or disposal of the sources or devices.
A civil penalty of $45,000 to a general licensee for loss or improper disposal would be approximately 8 times greater than the base civil penalty for other types of Severity Level i violations. The staff is further considering these issues and will make a final recommendation to the Commission and implement the Commission's decision concurrent with the effective date of the final rule, as per the April 13,1998, SRM.
-e. a
-The Commissioners 3' item 4 of the April 13,1998,' SRM addressed a materials risk review. Information on that action was provided to the Commission in SECY-99-062, dated March 1,1999. Item 8 addressed continued efforts on an orphan source program. This subject was discussed in SECY-99-038, dated February 3,1999, item 7 of that SRM directed the staff to provide an estimate of the resources needed to fully support this enhanced general license program. The staff has developed the table in Attachment 4. The table includes the resources needed to develop and fully support the registration program for the approximate 6000 general licensees identified in the SRM, as well as other aspects of the enhanced generallicense program. The staff notes that the resources identified in the table are included in the current FY 2000 budget and are being addressed in
' the FY 2001 budget.
In addition, Attachment 5 provides a partial response to a December 21,1998, SRM responding to SECY-98-232. In that SRM, the Commission directed the staff to estimate the resource impact of adding approximately 5000 portable moisture density gauges as generally licensed
- devices to the " pool" subject to the proposed registration program and whether the program's
- timeline as described _in SECY-98-199 would be negatively impacted.
DISCUSSION:
The proposed provisions delineating an annual registration requirement are essentially !
consistent with the plans for the registration process discussed in the first of these proposed l rules. The criteria for determining which devices would be included in the registration program i are those recommended by the working group. As part of the registration program, licensees j will be asked to verify information concerning the identification of devices, accountability for the !
devices, the persons responsible for compliance with the regulations, and the disposition of the !
devices. The staff estimates that approximately 6000 general licensees would be required to provide registration information annually. As directed by the Commission, the proposed rule
.would also add a registration fee.
The proposed rule would require that general licensees under 6'31.5 appoint a responsible .
individual through whom the general licensee will ensure day-to-day compliance with~the -
regulations. The distributor of the generally licensed product would have to obtain the name - jl
. and phone number of this person from its customers, rather than simply a contact, and provide this information to the NRC or the Agreement State in quarterly transf.er reports. For those registering devices, information on this responsible individual would be updated through the registration process. The serial number of devices would be added to the information reported in quarterly transfer reports and to reports of transfers by general licensees so that individual
~ devices can be tracked. Additionallabeling would be required to better ensure that devices can be identified as containing radioactivity and can also be traced back to the responsible party in the event of loss of control. There are some additional provisions, not addressed in the NRC-
' Agreement State recommendations, also intended to improve the accountability of devices
, generally licensed under $ 31.5 and to clarify the regulations pertaining to all generally licensed !
products containing byproduct material. !
~
- The proposed rule is intended to better ensure that certain general licensees are aware of ;
applicable requirements'and can account for their devices. Communication with general I licensees, accomplished primarily through registration, would provide NRC assurance of g
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The Commissioners 4' licensee accountability. The staff believes that if generallicensees were more aware of their responsibilities, they would be more likely to comply with the requirements for proper handling and disposal of generally licensed devices. This would reduce the potential for incidents that could result in unnecessary radiation exposure to the public and contamination of property.
The proposed rule is also intended to better allow NRC and the Agreement States to keep track
- of general licensees, including tracking of specific devices. Tracking the general licensees is important so that they can be contacted and inspected as appropriate. Tracking will also allow devices to be traced back to the owner in the event that they have been found in inappropriate locations or if a generic defect is identified in a group of devices.
The proposed amendments were provided to the Agreement States twice during its development via the use of the NRC Technical Conference Website and notification to the States of its availability. Input was received following the first posting through discussions at an All Agreement State meeting in October of 1998. The second posting was also available to the public. A notice of availability was published December 31,1998 (63 FR 72216).
RESOURCES:
. The resources needed to complete this action are in the current budget.
COORDINATION:
The Office of the General Counsel has no legal objection to the proposed rulemaking. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has no objections. The Office of the Chief information Officer has reviewed the proposed rule for information technology and information management implications and concurs in it. However, the proposed rule would amend information collection requirements. The package requesting review and approval of the amended information collection requirements must be received by the Office of Management and Budget no later than the date the rule is published in the Federal Reaister.
RECOMMENDATIONS:
That the Commission:
- 1. 'Aporove the notice of proposed rulemaking (Attachment 3).
- 2. Certify that this rule, if adopted, will not have a significant impact on a substantial number of small entities, to satisfy the requirements of the Regulatory Flexibility Act,5 U.S.C. 605(b).
- 3. Note:
"a. The rulemaking will be published in the Federal Reaister for a 75-day public comment period.
- b. This rule has been reviewed by the Agreement States.
e a The Commissioners 5
- c. Neither an environmental impact statement nor an environmental assessment has been prepared because the provisions in this proposed rule are the types of actions described in the categorical exclusions in @ 51.22(c)(1) through (3).
- d. A draft regulatory analysis has been prepared and will be available in the Public Document Room (Attachment 6).
- e. The appropriate Congressional committees will be informed (Attachment 7).
- f. The Chief Counsel for Advocacy of the Small Business Administration will be inforrned of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act.
- g. The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.). These requirements will be forwarded to the Office of Management and Budget for approval.
- h. A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 8).
- i. An optional Form XXX will be made available for distributors' quarterly transfer reports.
(Attachment 9)
- j. Draft guidance for licenses for distribution to general licensees will be published for comment. A brief appendix for use in providing guidance to 10 CFR 31.5 general licensees is included. (Attachment 10) f WY M William D. Travers Executive Director for Operations Attachments:
- 1. April 13,1998, SRM
- 2. Analysis of Fee Structure Options
- 3. Draft Federal Register Notice
- 4. Resource Estimate for General License Program
- 5. Impact on Resources and Timeline of Converting Portable Moisture Density Gauges to Registered Generally Licensed Devices
- 6. Draft Regulatory Analysis
- 7. Draft Congressional Letters
- 8. Draft Press Release j 9. Draft Form XXX - Transfers of Industrial Devices Report i 10. Draft NUREG-1556, Vol.16 L
6 Commissioners' completed vote sheets / comments should be provided directly to the Office of the Secretary by COB Monday, April 26, 1999.
Commission Staff Office comments, if any, should be submitted to the Commissioners l NLT April 19, 1999, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC OCAA OIG' OPA OCA CIO CFO EDO REGIONS SECY l
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ATTACHMENT 1 April 13,1998, SRM l
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. ;? }o NUCLEAR REGULATORY COMMISSION se WASHINGTON. o C 20555-0001 U I k.s / April 13, 1998 4.....
OFFICE OF THE SECRETARY MEMORANDUM TO: L. Joseph Callan Executive Director for Operations Jesse L. Funches Chief Financial Officer William M. Beecher, Director Office of Public Affairs f
/M b Mnnette L. Vietti-Coobing Secretary FROM:
SUBJECT:
STAFF REQUIREMENTS - SECY-97-273 - STAFF REQUIREMENTS - SECY-96-221 "lMPROVING NRC'S CONTROL OVER, AND LICENSEES' ACCOUNTABILITY FOR, GENERA'.LY AND SPECIFICALLY LICENSED DEVICES" The Commission had disapproved the staff's recommendation and directs the staff take the following actions:
- 1. Terminate the rulemaking on 10 CFR Part 31.5 that was initiated in 1991 except those provisions that will enable NRC to request information from certain general licensees to provide the regulatory basis for initiation of a registration program in advance of the rulemaking described below. Those portions of the 1991 proposed rule should be renoticed for public comment.
(EDO) (SECY Suspense: 8/21/98)
- 2. Provide a set of milestones to the Commission for information for implemerticg the rulemaking described below. The milestones should be in lieu of the standsid rulemaking r>lan required by Management Directive 6.3, but should meet the requirement for coordination with Agreement States.
(EDQ / (SECY Suspense: 8/21/98)
SECY NOTE: SECY-97-273 WAS RELEASED TO THE PUBLIC ON DECEMBER 2,1997.
THIS SRM AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
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- 3. Draft a proposed rule to implement a registration and follow up program for the i generally-licensed sources / devices identified by the NRC Agreement State Working Group, apply fees to these general licensees, and incorporate requirements for permanent labeling of sources / devices. The proposed rule should include the staff's preferred approach - Attachment item 11, Option 3 - to apply a registration fee, per licensee, at the time of initial registration and annual re-registration of sources / devices.
The staff should explore the possibilities, advantages, and disadvantages of other fee l
approaches such as pro-rating the fees, e g., per device (fixed or sliding scale) or per license and provide recommendations to the Commission. Determine the extent to which application of the small business rule will affect the fees.
(SECY Suspense: 12/31/98)
(EDO/CFO) l
- 4. Use the results of the materials risk assessment study to restructure the current l
licensing and materials programs. Consider the findings when determining whether additional sourns/ devices should be subject to registration and follow up, and for l
performing the risk ranking necessary if a phase-in approach is used to reduce the initial resource surge associated with an increased regulatory program. Review the basis of the generallicenses for adequacy with respect to consideration of the consequences of off-site accidents, such as loss of shielding or melting in metal making fumaces. The
! staff should provide the technical basis document for the risk assessment together with l
recommendations on how to proceed.
l (EDO) (SECY Suspense: 12/31/98) l
- 5. Include provisions in the registration program for follow up of cases where there are no responses or where discrepancies are found between responses and NRC records, Explore with vendors their willingness to voluntarily assist the NRC (and Agreement l' States) in the follow up effort. Develop follow up procedures which integrate the followng fundamental concepts:
a the extent of follow up should consider the risk to public health and safety that the source or device in question poses as well as the likelihood of finding the device;
- b. considenng the associated level of risk, there should be a point at which the follow up of certain low risk sources and devices is terminated;
- c. allinformation about lost sources should be made public in a timely manner.
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(SECY Suspense: concurrent with effective date (EDO) for final rule)
- 6. Implement an enforcement program that includes a short amnesty program for general licensues and increased civil penalties for bo'.h general and specific licensees for " lost" sources. The increased civil penalties should be significantly greater than the costs of proper disposal or transfer of a source or device. Work with Agreement States in
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l implementing enforcement programs such that their policies. practices, and procedures have the same impact as NRC's enforcement program. l (SECY Suspense: concurrent with effective date (EDO) for final rule) 7 Provide an estimate of the resources needed to fully support this program. Preparation of this estimate should include:
o Estimating resource needs for the various phases of the registration program including,in particular, the substantial" spike" of resources needed to carry out the follow up program.
o Reviewing registration programs for generallicensees that have been implemented by Agreement States for applicability of concepts, and exploring the l
possibilit; of utilizing other Federal agency registration programs and off-the-shelf commercial programs to minimize development and operating costs.
o Exploring the possibility of contracting with the States to carry out this part of the program under authority of Section 274i of the Atomic Energy Act, as amended.
o identifying, through the Executive Council, resources to support the expanded program, and inform the Commission if other program areas need to be reduced.
The Executive Council c,hould consider program areas outside of NMSS. The Executive Council should also evaluate and inform the Commission of the impact of this change on the Strategic Plan, Strategic Goals, and specific programs.
(SECY Suspense: 12/31/98)
(EDO)
- 8. Continue efforts to further address the orphan sources. A guiding principle is that non-licensees who find themselves to be in possession of radioactive sources that they did not seek to possess should not be expected or asked to assume responsibility and cost for exercising control or arranging for their disposal. These efforts should include:
o Consulting with DOE, EPA, FEMA and the States to defse jurisdictions and tegulatory responsibilities for addressing the orphan source problem, and continued close coordination with the Conference of Radiation Control Program Directors to ensure that a similar regulatory framework is applied to source / devices containing Atomic Energy Act (AEA) material and sources / devices containing naturally-occurring or accelerator-produced radioactive material.
o The staff should aggressively pursue finalizing the MOU with DOE.
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o Consider the pros and cons of establishing a contract program that would enable l
licensees or DOE to take possession of and arrange for proper transfer or disposal of orphan sources and provide an estimate of the costs of such a program.
(SF.CY Suspense: 12/31/98)
(EDO) o if NRC funding is necessary for an orphan source recovery program, the staff should provide recommendations for funding the program including, as directed by the Commission in its December 1996 SRM, " exploring with Congress the possibility of removing specific program costs from the NRC's user fee base (e.g., orphan source recovery fund)."
(SECY Suspense: 12/31/98)
(CFO)
The Office of Public Affairs should issue a press release concerning the Commission's decision.
(SECY Suspense: 4/15/98)
(OPA)
Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC CIO 1 CFO !
OCA OlG
.. Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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-e Analysis of Fee Structure Options ;
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ANALYSIS OF FEE STRUCTURE OPTIONS l This addresses the cdvantages and disadvantages of charging fees on a per device or per
! licensee basis and issues relating to the Regulatory Flexibility Act.
l Backaround l In reviewing alternative methods for assessing a registration fee, the staff considered the NRC's longstanding policies governing the methods by which fees for services are assessed to
- other applicants and licensees. Currently, for small materials users, fees for specified amounts l by fee category (" flat" fees) are assessed under Part 170 for applications for new licenses.
These flat fees are based on the average professional staff time to conduct reviews of these applications. The flat fee is not based on an economic value to the licensees, such as how l
( much material is possessed, frequency and uses, or sales generated from using licensed !
L materials.
l In the July'10,1991, final fee rule (56 FR 31511), the NRC addressed in its Regulatory y . Flexibility Act Analysis, the approach for assessing annual fees to small entities. In comments
! . received on the FY 1991 fee rule, licensees proposed that the NRC should base the annual fee ;
- on some economic value to licensees or other indicators as a justification for reducing the j l annual fee. The Commission did not adopt the approach recommended by licensees for the j following reasons
- (1) assessing fees based on economic value, not regulatory costs, would s Muire licensees to submit significantly more information and would require additional NRC !
- staff to evaluate the information submitted and to develop and administer even more complex ,
1- fee schedules; (2) the NRC application fee did not have a significant impact on small entities; l and (3) in Agreement State jurisdictions, the States charged comparable fees to small entities.
l The NRC rejected the suggested approach in part because a large diversified firm that owns one source would get a reduced fee, while a small entity, whose business may depend sclely >
l on the use of radioactive materials would pay a disproportionate fee because it has more than ;
one source. In that example, the impact of the fee would be adverse to small entities.
I Moreover, the basis for charging fees to licensees is to recover the agency's costs in providing
. an identifiable service irrespective of the economic benefits a licensee may receive. Another i
fundamental principle of.NRC policy is that the process should be a simple one making it easy l for licensees to understand and for staff to administer. In the Regulatory Flexibility Act Analysis - l
- for the FY1991 final fee rule, the NRC determined that the annual fees for small materials licensees should not be based on the direct proportion or amount of material (e.g., number of l
- devices) possessed by a licensee. The NRC also reaffirmed this policy decision in its February i 1994 Report to Congress on the Commission's review of license fee policies.
Discussion Although general licensees would be required to register each device with the NRC under the
. proposed registration program, NMSS indicates that the agency's cost to register a general l licensee's devices is projected to be nearly the same regardless of the number of L sources / devices possessed by the licensee.
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, Basing fees on the number of devices or a sliding scale would not necessarily meet the intent of l , independent Offices Appropriation Act, i.e., that fees recover the agency's cost in providing the service. In addition, these methods would complicate the fee recovery process, not only for L L NRC but for the registrants as well. With the uncertainty of the licensees' status from one year L to the next, the' additional tracking and reconciliation of the fee based on the number of devices
^ possessed from year to year would not be cost effective, considering the total amount projected to be recovered for the registration program.
~As requested in the April 13,1998 SRM, staff examined establishing a sliding scale method for
' fees based on the number of devices. For example, a sliding schedule of separate flat fees L could be established as follows: 1 to 15 devices = X dollars; 16 to 50 devices = Y dollars; and over 51 devices = Z dollars. The determination of such category breaks would be subjective.
The Commission has previously rejected this approach in establishing fees.
- Adoption of either approach (number of devices or sliding scale) would set an undesirable precedent. It also would require a number of licensees to submit information to the Commission for review and result in additional administrative burdens as discussed above. As the number of devices could vary from year to year, licensees would need to submit the l- appropriate amount with the registration. This method goes against the principle of keeping the l concept simple. The staff believes that basing the fee on a per device basis or by a sliding scale would not result in a fair and equitable allocation of its regulatory costs, and would not achieve the goal of the Regulatory Flexibility Act to reduce the impact of fees on small entities.
The staff also reviewed the method for assessing the fee to general licensees based on the actual cost for each individual review and determined that the resulting increases in
. administrative costs to account for the effort expended for the review of each registration filed I would exceed, in many cases, the average costs to be recovered for the general license
- registration program. The staff does not believe this method to be a cost effective or viable approach.
The method of assessing a flat ioe to the registrants, based on the average costs of the program per licensee, would be consistent with the method used to assess flat fees to specifically licensed small materials licensees that file applications with the NRC. As provided
- in the proposed rule, general licensees would be subject to a flat fee irrespective of the number of devices the licensees possess. We estimate the fee to be $370 per registration. The costs include all costs of the program for this population of general licensees including the processing .
' and reviewing of registrations and the followup on identified noncompliance with regulations, including current regulations.
This fee assumes that the resources budgeted for the program will average 8 FTE and $ 400K f (or approximately $2.2M) per fiscal year (FY 2001 - FY 2003). To ensure the agency recovers its costs for the program from those licensees that derive a benefit from the program, the registration fee should be assessed for each registration filed with the agency. Therefore, a general licensee that submits multiple registration filings (e.g., based on location of the sources / devices) would pay the registration fee for each of its filings, it is anticipated that the composition of the general licensees will be similar to that of the existing specific licensees. The approximate registration fee of $370 is less than the lowest-tier 2
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i annual fee of $400 paid currently by small entities. Based on input received previously from small entities who hold materials licenses, the staff believes that the proposed $370 Part 170 ,
annual registration fee would not have a significant economic impact on a substantial number of small entities. Nonetheless, the staff plans to solicit comments from the affected general
~ licensees on whether the proposed Part 170 fee for the annual registrations would have a j
. significant economic impact on them.
The initial program startup costs through FY 2000 would not be recovered from the general
. licensees; instead these costs would be recovered from the annual fees paid by current holders of specific licenses, registrations, and approvals. Thus, the proposed rule indicates that the conforming changes to Part 170 to include the registration fee would become effective October 1,2000 (FY 2001) or later, depending on the actual implementation date of the registration process. This would allow general licensees sufficient time to budget for the fee or determine whether they wish to relinquish their general license to avoid the registration fee.
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ATTACHMENT 3 i
Federal Register Notice ;
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[7590-01-P]
l NUCLEAR REGULATORY COMMISSION 10 CFR Pads 30,31,32,170, and 171 1
I RIN 3150 - AG03 i
Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material j l
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations goveming the use of byproduct materialin certain measuring, gauging, or controlling devices.
The proposed amendments would include adding explicit requirements for a registration j l
= process that the NRC plans to initiate through a related ruiernaking, would add a registration fee, and would clarify _which provisions of the regulations apply to all general licenses for j byproduct material. The proposed rule would also modify the quarterly transfer reporting, recordkeeping, and labeling requirements for specific licensees who distribute these generally i
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' licensed devices. The proposed rule is intended to allow the NRC to better track certain l general licensees and the devices they possess and to further ensure that general licensees i ~
i are aware of and understand the requirements for the possession of devices containing byproduct material, j i
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' DATES: Submit comments by (Insert date 75 days after publication date). Comments received
. after this date will be considered if it is practical to do so, but the Commission is able to ensure f- .
consideration only for comments received on or before this date.
I ADDRESSES: Send comments by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: . Rulemakings and Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 am
- and 4:15 pm on Federal workdays.
You may also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc. gov). This site provides the availability to upload
- comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-5905; e-mail CAG @ nrc. gov.-
Certain documents related to this rulemaking, including comments received and the regulatory analysis, may be examined at the NRC Public Document Room,2120 L Street NW.
(Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.
> FOR FURTHER INTCRMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,
- telephone (301) 415-6264, or e-mail at CRMenrc. gov.
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SUPPLEMENTARY INFORMATION:
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Background
I On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended i
- its regulations to provide a generallicense (10 CFR 30.21(c)) for the use of byproduct material i
contained in certain measuring, gauging, or controlling devices. Under current regulations in 10 CFR 31.5, certain persons may receive and use a device containing byproduct material 1
under this general license if the device has been manufactured and distributed according to a specific license issued by the NRC or by an Agreement State. A specific license authorizing 1
distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for its safe operation are adequate and meet regulatory requirements.
.The person or firm who receives such a device is a general licensee. These general 4
licensees are subject to requirements for maintaining labels, following instructions for safe use, J
- storing or disposing of the device properly, and reporting transfers and failure of or damage to the device. For some devicec, the general licensee must also comply with testing requiremerAs for leakage and for proper operation of on-off mechanisms. General licensees are also subject
. to the terms and conditions in 6 31.2 concerning general license requirements, transfer of -
byproduct material, reporting and recordkeeping, and inspection. General licensees must
- comply with the safety instructions contained in or referenced on the label of the device and i
- must have the testing or servicing of the device performed by an individual who is authorized to m'a'nufacture, install, or service these devices except as indicated on the label.
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o e A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded housing. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license simplifies the licensing process so that a case-by-case determination of the adequacy of
.the radiation training or experience of each user is not necessary.
. There are about 45,000 general licensees authorized by Q 31.5 to possess about
- 600,000 devices that contain byproduct material. The NRC has not contacted or inspected
. these general licensees on a regular basis because of the relatively small radiation risk posed by these devices.
Individuals who possess devices under this generallicense are not always aware of
- applicable requirements and thus are not necessarily complying with all of these requirements.
The NRC is most concemed about occurrences where generally licensed devices have not been handled or disposed of properly, in some cases, this has resulted in radiation exposure to the public and contamination of property. Some generally licensed devices have been accidentally melted in steel mills causing considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust. Although known exposures have generally not exceeded the public dose limits, there is a potential for significant exposures.
The NRC conducted a 3-year sampling (1984 through 1986) of general licensees to assess the effectiveness of the general license program. The sampling revealed several areas of concem regarding the use of generallicensed devices. The NRC concluded that -
' (1) Many general licensees are unaware of the regulations that apply to the possession of a generally licensed device and; (2) Many general licensees are unable to account for their devices.
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' Approximately 15 pe'rcent of the generallicensees sampled could not account for all of i
. their generally licensed devices. The NRC concluded that these problems could be resolved by more frequent and timely contact between general licensees and the NRC.
- On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking concerning the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement under 6 31.5 for general licensees to
- provide information to the NRC upon request, through which a device registry could be l
- . developed. The proposed rule also included requirements in Q 32.51a and 32.52 for specific licensees who manufacture or initially transfer generally licensed devices. Although the public
.. comments received were reviewed and a final rule developed, a final rule was not issued
'because the resources to fully implement the rule were not available.
The NRC has continued to consider the issues relateo to the loss of control of generally j licensed, as well as specifically licensed, devices. In July 1995, the NRC, with assi. stance from p the Organization of Agreement States, formed a working group to evaluate these issues. The h
working group consisted of both NRC and Agreement State regulatory personnel and
. encouraged the involvement of all persons having a stake in the process and its final
. recommendations. All working group meetings were open to the public. A final report was
- published in October 1996 as NUREG-1551, " Final Report of the NRC-Agreement State
,. Working Group to Evaluate Control and Accountability of Licensed Devices."
,in considering the recommendations of this working group, the NRC decided, among
[ - other things, to again initiste rulemaking to establish an annual registration of devices generally L ,
- licensed under 6 31.5.' This registration program would be similar to the program originally l
proposed in the 1991 proposed rule. However, it would apply only to those devices considered p .
to_ present a higher risk of potential exposure of the public or property loss in the case of loss of 4
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control (c,ompared to other generally licensed devices), initially, the NRC has been using the criteria developed by the working group for determining which sources should be subject to the registration program. Using these criteria, it is estimated that the registration requirement
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- would ' apply to about 6000 general licensees possessing about 24,000 devices. These criteria
- were based on considerations of relative risk and are limited to radionuclides currently in use in these types of devices. If quantities of other radionuclides that would present a similar risk are used in these devices in the future, the criteria may be revised to include additional radionuclides. The Commission may also consider revising the criteria to include a larger number of devices in the registration requirement for other reasons in future rulemaking.
The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC with the
- authority to request informatio,1 from its licensees concerning licensed activities. However, the tCommission had not included an explicit provision in its regulations that would require { 31.5 general licensees to provide information on request. On December 2,1998 (63 FR 66492), the Commission published a proposed rule that would explicitly require general licensees who possess certain measuring, gauging, or controlling devices to provide the NRC with information about the devices. Assuming it becomes a final rule, the NRC intends to use that provision
- primarily to institute a registration and accounting system for the devices containing certain
- quantities of specific radionuclides that present a higher risk of exposure to the public or property damage if a device were lost. That rulemaking was not proposed as a matter of compatibility for Agreement States.
This proposed rule would add specific requirements concerning the registration of devices'and additional provisions of an enhanced regulatory oversight program for all general licensees to be registered. The proposed rule would also establish levels of compatibility for p
Agreement' State' regulations so that an increased level of oversight for general licensees in 9
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Agreement States would also be required. Some States have already instituted some form of enhanced oversight for these general licensees. In a few cases, States have instituted a
. registration program. A few States have a higher level of control on these devices through requiring specific licenses. Under the proposed level of compatibility for 31.S, the essential objectives of the regulation should be adopted by the State to avoid conflicts, duplications, or gaps. However, the manner in which the essential objectives of the regulation are addressed
,need not be the same as NRC. Strict compatibility would only be required for revisions to the
. requirements applicable to distributors because of interjurisdictional distribution.
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i Discussion i
The December.2,1998, proposed rule would provide one of the key elements in I
improving the accountability and contro', over devices of particular concern through the l institution of a registration process. Howaver, current regulatory provisions are inadequate to allow for the NRC to track general licensees and the specific devices they possess. The NRC ' l 1
needs to track these general licensees in order that they can be contacted or inspected when appropriate. The NRC also needs to track specific generally licen ,ed devices, so that the responsible party can be identified when a device is found in an inappropriate situation. j Tracking devices would also allow the NRC to contact the appropriate general licensees if a l
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. generic defect in a group of devices is identified. As noted, that proposed rule would not require Agreement State regulations to be compatible.
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' There are other means for reducing the likelihood of incidents of lost sources. The Commission has reconsidered the provisions in its 1991 proposed rule, evaluated the 7
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? recommendations of the NRC-Agreement State Working Group, and identified additional issues conceming these devices in developing this proposed rule.
Summary and Discussion of Proposed Requirements Revisions to the Requirements for General Licensees under $ 31.5. This proposed l
rule would add explicit provisions delineating an annual registration requirement. The registration process would be initiated under f 31.5(c)(11), proposed on December 2,1998, if
' that requirement is adopted in a final rule. Proposed 9 31.5(c)(11) would require licensees to respond to requests for information from NRC within 30 days or as otherwise specified. The provisions proposed in this document (new 6 31.5(c)(13)) are essentially consistent with the Commission's plans for the registration process discussed in the December 2,1998, proposed rule. This proposed rule would specifically require that the information about devices be verified through a physical inventory and by checking label information. The advantage of including more explicit requirements in the regulation is that in'ormation about the registration process will be more clearly defined and more available. When the distributor of a device supplies copies of 6 31.5 to its customers (under 6 32.51e(a)), the potential general licensees would be made aware of the registration requirement, the devices to which it applies, the information to be requested, and the registration fee.
The proposed rule would add a fee of $370 to f 170.31 to be assessed in conjunction with the annual registration process. This registration fee would be for each general licensee possessing devices required to be registered regardless of the number of devices. The NRC is required by law to recover approximately 100% of its budget from licensees' fees. The proposed registration fees would recover the cost of the general license program associated 8
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with this group of general 6censees in an equitable way, as required by law. Those who are allowed to use devices under the general license would bear the cost of the program instead of those who hold specific licenses.
I Rather than provide blank forms such as are used in other of the Commission's registration programs, it is planned to send a registration form or certificate with the information l- recorded in the Commission's database la a request for registration, which would ask the general licensee *o verify, correct, and/or add to the inforrnation provided. This would be similar
! to the approach typically used by States for the renewal of automobile registrations. This is intended to be more efficient for the general licensees and the Commission.
The first registration that would be carried out under 6 31.5(c)(11) would depend on the l
NRC's ability to contact general licensees because the NRC must request the information. This proposed rule also specifies that the general licensee would complete registration by verifying,
- correcting, and/or adding to the information in a request for registration received from the I I
Commission. It is silent on when or how general licensees should register if the Commission fails to contact the generallicensee. The Commission seeks comment on whether the registration requirement should include a provision that would require the general licensee to complete registration by a certain time, such as 15 months after: the date of the previous
- registration certificate, the receipt of a device subject to registration, or the effective date of this rule for an unregistered device possessed at the time of the effective date of a final rule enacted in response to this proposed rule. This would put the burden of registering on general licensees who have not been notified by the NRC of the requirement.
The time of year for registration would vary for licensees. However, requests for renewal of registration would be made approximately 1 year after the previous registration request for that licensee. Although registration would not be required before the receipt of a i
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device, the Commission plans to send requests for registration to new general licensees subject to registration that are identified in distributors' quarterly transfer reports submitted under
<< 6 32.52 shortly after this information is received and recorded. If a general licensee has previously registered devices and receives additional devices requiring registration, the new devices would be registered when the annual reregistration is carried out. TM Commission requests comment on whether the NRC should have earlier contact with presous registrants who receive additional devices, either by an acknowledgment by NRC to the user or by a required response from the general licensee that accounts for the additional device (s). The effective date of the registration fee w be set to apply after the initial registration requests have been sent for response under 9 31.5(c)(11) so that the first round of annual registration will be complete prior to this effective date and the fee will be imposed with the first reregistration for all devices currently in use.
The proposed rule would establish additional requirements for all general licensees under 9 31.5. These proposed requirements include:
(1) an explicit requirement for the general licensee to appoint an individual assigned responsibility for knowing what regulatory requirements are applicable and having authority to take required actions to comply with the applicable regulations and through whom the general licensee. carries out its responsibilities to comply with the applicable regulations (new
$ 31.5(c)(12));
(2) a provision that limits the amount of time a general licensee can keep an unused device in storage and allows the deferment of testing during the period of storage (new 31.5(c)(15));
(3) a provision to allow transfers to specific licensees authorized under part 30, or 1
- equivalent Agreement State regulations, as waste collectors, in addition to currently allowed I 10
s e.
J transfers to part 32 (and Agreement State) licensees; to allow transfers to other specific
. licensees but only with prior written NRC approval; and to add the recipient's license number, the serial number of the device, and the date of transfer to the information required to be
. provided to NRC upon transfer of a device (revision of 6 31.5(c)(8));
!. (4) a provision to notify NRC of address changes (new 6 31.5(c)(14));
- (5) for device damage or failures that are likely to. or are known to have resulted in contamination, the addition of a plan for ensuring that premises and environs are suitable for-unrestricted access, to the information that must be sent to NRC in the case of a failure; a
' change to the addressee for reporting information concerning a failure; and a note that the criteria in { 20.1402, " Radiological criteria for unrestricted use," may be applied by the
' Commission in the case of contamination in spite of the exemption in 9 31.5(c)(10) (revision to
{ 31.5(c)(5)); and (6) a revision of the reporting requirement, in the case of a transfer to a general licensee taking over possession of a device at the same location, to provide the serial number of the device and the name and phone number for the person designated as the responsible individual, rather than simply a contact name (revision to 9 31.5(9)(i)).
The rationale for each of these proposed amendments is:
(1) New f 31.5(c)(12)- Responsible person. The " person" who holds a general license
? is usually a corporation, or public or private institution, rather than an individual. In practice, in order for the general licensee to comply with existing regulations, an individual in the corporation or institution must be aware of the requirements and be authorized to take the
. required actions.' Appointing a specific individual to be responsible for knowing roout and taking actions to comply with regulations is'an appropriate operational practice, which, unfortunately, is not always followed. If a device is not subject to testing under 9 31.5(c)(2),
'11
5 J there are no routine actions required to be taken, because the requirements are generally restrictions on actions, such as not abandoning the device, or actions to be taken only in the case of particular, non-routine events, such as notification of NRC of the transfer or failure of the device. It is this type of situation, where knowledge of the nature of the device, the general license, and the associated regulations is unlikely to be maintained and passed on to individuals using the device. Requiring the assignment of the responsibility for knowing and having authority to take required actions for complying with regulations to a specific individual would improve the probability that the gene Clicensees will do what they are already required to do.
The impact of this should be minimal, somewhat limiting operational flexibility with regard to the assignment of duties. This individual does not have to work on site at the place of use of the device and does not have to conduct all required actions, but would be responsible to ensure that the generallicensee is aware of required actions to be taken. This assignment does not relieve the generallicensee of responsibility.
(2) New $ 31.5(c)(15) - Timeliness of disposition and deferral of testing while in storage.
When a device is not in use for a prolonged time, it is particularly susceptible to being forgotten and ultimately disposed of or transferred inappropriately. Generallicensees are unlikely to keep a device unused for more than 2 years and subsequently use it. If a device is being held in storage indefinitely, it is likely that it is being stored to avoid the costs of proper disposal. If a generallicensee intends to use a device after a period of more than 2 years of nonuse, the device could be sent back to the supplier to be held under the distributor's specific license until later use, or the general licensee could request an exemption from 31.5(c)(15) indicating the reason (s) why the licensee intends to use the device after 2 years and prefers to keep it on site in the interim.
12 l
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co, c L
.lf a period of storage exceeds the normalinterval for testing, testing would not need to be done until the device is to be put back into use again. This would relieve the burden of
~
~ unnecessary testing during the period of storage as well as eliminate any unnecessary exposure that could occur during testing for that period.
(3) Revision to 6 31.5(c)(8) - Provisions for transfers to specific licensees. This proposed revision would provide some flexibility to the general licensee in transferring a device
. while ensuring that it is transferred appropriately. It would allow a general licensee to transfer a device directly to a waste collector for disposal, rather than going through a distributor. It would
. also allow the transfer of a device to other specific licensees, but would require NRC approval in these cases so that NRC can ensure that the recipient is authorized to receive the device.
.The inclusion of a recipient's license number in the report of transfer would better
- ensure that the general licensee has verified that the recipient is a part 32 licensee, a part 30 waste collection licensee, or a specific licensee under equivalent Agreement State regulations authorized to receive it. It would also supply an additional means for NRC to identify the recipient, because company names and addresses sometimes change. The addition of the l l
date of transfer will make the transfer easier to track and help to ensure that the general l, licensee makes the report in a timely manner (required within 30 days of transfer).
(4) New 6 31.5(c)(14) - Change of address notification. The quarterly reports required of distributors under 66 32.52(a) and (b) are intended to provide NRC and the Agreement State !
i regulatory agencies with the idetity of general licensees in their jurisdictions and addresses at which these general licensees can be contacted (proposed to now be specifically the mailing address for the location of use of the generally licensed device). These general licensees can i
then be contacted or inspected.' If general licensees move their operations without notifying the I NRC, or appropriate Agreement State agency, they may be difficult to locate. This proposed I
13 i
e L1 j
p s a L - requirement to report address changes would only apply to previously supplied mailing
- eddresses and, for portable devices, the mailing address for the primary place of storage,
' . although the devices may be used at multiple field sites. For those registering devices, other changes in addresses, if different from the mailing address for the location of use, will be provided at the time of the next registration.
This simple change of address notification is intended to track moves into and within
- NRC jurisdiction. The general license in 6 31.5 only applies to persons within NRC jurisdiction.
, if a general licensee intends to move from one jurisdiction to another, it should contact the applicable regulatory authority, NRC or the particular Agreement State, before doing so to determine the applicable, current regulations in that jurisdiction. All jurisdictions do not have a
. comparable general license and specific provisions of the general license may vary among jurisdictions. If a generallicensee has obtained a portable device in an Agreement State and
- - - wishes to use the device within NRC jurisdiction, it must do so under 9 31.5, because there is no reciprocity provision applicable to general licenses.' in this case, they would be subject to the provisions of 6 31.5.
. (5) Revision to 6 31.5(c)(5) - Reports of device failures. General licensees are not
' subject to decommissioning requirements.- A general license is granted by regulation and, under normal circumstances, does not involve any termination of license process, if a generally
- licensed device fails or is seriously damaged so as to cause significant contamination of the Ipremises or environs, the NRC may need to respond to the notification of an incident made under 6 31.5(c)(5) to ensure that a facility is properly decontaminated. Following such an incident, the NRC would determine what actions are necessary on a case-by-case basis and, if necessary, would' apply the criteria set out in 6 20.1402, " Radiological criteria for unrestricted use." The general licensee is exempt from this section of part 20 when in possession of an 14
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A Major Problemfor Steel Companies and Their Workers i The steelIndustry is being Of this total. sixteen incidents pCOHOmic exposed to radioactive took p?acein US EAF steel mills.
materials in the ferrous Fortunatety, none of these bff0CIS scrap supply. Radioactive incidents resulted in worker scrap has been arriving with injuries or loss o' life, but did The economic ef'ects of the increasing frequency at steel cause major economic injury. radioactive source prob'em mill truck and rail gates In the include: the cost of purchasing form of: Radioactive sources have been sophisticated delection discovered in shipments of systems, training personnel in
--radioactive sources. scrap in the US at an afamiing detection, and the delays in typica!Iy used in measuring rate. steelmaking operations, costs gauges in manufacturing for disposal of sources that operations that have shut Typically they are Cesium-137 steal companies find, and, down, or from obsolete orCobalt-60sourcesshieldedin worst of all, for a company that hosprtal equipment, shielded lead.andwere usedinmeasuring has inadvertently melted a in load gauges in a variety of radioactue source. millions of i
manufacturing operations, such dollars of clean-up costs and pipe used in oil-drilling as poper mills and breweries, costs of shutting down )
I operations contaminated with They are usually genera!!y operat;ons for clean up.
residues from oil drilling and licensed
- sources.
Penalties for ~ losing" a source,
-scrap from decommis- SMA member companies are ontheotherhand,arerninuscule sioned nudear power and US innocent victims of inadequate sometimes a fine of one ortwo Departmentof Energy (" DOE') control of radica6ve devices. thousand dollars, levied against facihties. the negligent licensee for a in response to the presence of source that would cost a steet in addition to presenting risks radioactive de' ices in the scrap company millions of dohars, to the health and safety cf supply, steel companies have workers and the environment, installed arW use sophisticated There is little deterrent if a radioactive scrap threatens radiation cetection systems to negilgent owner of a source the economic survival of steel monito' all incoming shipments loses or discards it, as the companies and forces upon of scrr.p. by truck, rail or vessel, fines imposed by the NRC for them costly operating loss or negligence are totally expenditures and losses. Shielded radioactive sources, inadequate.
such as Cesium-t37 or Cobalt-in the past fifteen years,49 60, if inadvertently melted in a The costs associated with known incidents have taken steel mill, can contaminate mill decontaminating a facihty after place world-wide where equiprnent and ' by-product an inadvertent melting of a metais companies inadver- materials of the steel making radioactive dev'rce can range tently rnetted shleided process. between 12 malion and 524 radioactive sources. million.
088 3/3r/f7llage: S 2 Post-it* Fax Note 7671 Current ELGs for the steelindustry have been in place 1984. EPA has begun the process of revis;ng tne ELGs ft to gjf[ j.) ,'/[ w 7A A,'c3d iron and steelindustry. c ,o pi.
g co. 94 g _
ELGs are based on EPA's determination of the 'best practi
"" * * " " 2o7./2 f P)St.5 control technology currently available" for water pollution ci r. e gg , 4 p-'
Faz e g in the stealindus try, taking into account the cost of :he techo versus the potential effluent reductions. .
To determino the best practicable control technology for the in the meantPne, the SMA will continue to work cooperatively with EPA in the development of new steet ELGs.
Industry, EPA is sending steel plants across the country a survey form, completion of wNch is manda'ory.
eum- mour.wimiewmous 23
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