ML23153A062
| ML23153A062 | |
| Person / Time | |
|---|---|
| Issue date: | 12/27/1991 |
| From: | Taylor J NRC/EDO |
| To: | |
| References | |
| PR-031, PR-032, 56FR67011 | |
| Download: ML23153A062 (1) | |
Text
DOCUMENT DATE:
TITLE:
CASE
REFERENCE:
KEYWORD:
ADAMS Template: SECY-067 12/27/1991 PR-031, 032 - 56FR6701 1 - REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL PR-031, 032 56FR67011 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete
STATUS OP RULEMAKING PROPOSED ROLE:
PR-031, 032 OPEN ITEM (Y/N) N RULE NAME:
REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL PROPOSED RULE FED REG CITE:
56FR67011 PROPOSED RULE PUBLICATION DATE:
12/27/91 NUMBER OP COMMENTS:
ORIGINAL DATE FOR COMMENTS:
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EXTENSION DATE:
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FINAL RULB FED. REG. CITE:
FINAL RULE PUBLICATION DATE:
26 NOTES ON SECY 91-275 (NEGATIVE CONSENT) TO OBTAIN COMMISSION APPROVAL; STATUS 08/27/91.
FILE LOCATED ON 16TH FLOOR.
F -RULB I
I TO FIND THE STAFF CONTACT OR VIEW THE RULEMAKING HISTORY PRESS PAGE DOWN KEY HISTORY OF THE RULE PART AFFECTED: PR-031, 032 RULE TITLE:
REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL ROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER:
SRM DATE:
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SIGNED BY SECRETARY:
FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER:
SRM DATE:
I I
SIGNED BY SECRETARY:
STAFF CONTACTS ON THE RULE CONTACTl: JOSEPH J. MATE MAIL STOP: NLS129 PHONE:
CONTACT2:
MAIL STOP:
PHONE:
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492-3795
DOCKET NO. PR-031, 032 (56FR67011)
In the Matter of REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/12/91 01/14/92 01/09/92 FEDERAL REGISTER NOTICE - PROPOSED RULE COMMENT OF JOHNSON WAX (GENE I. MATSUMOTO) (
02/07/92 01/31/92 COMMENT OF BETHLEHEM STEEL CORPORATION
{EDWIN H. TOOTHMAN} (
- 2) 03/02/92 02/18/92 COMMENT OF OVERHOFF TECHNOLOGY CORPORATION
{M. W. OVERHOFF, PH.D.) (
- 3) 03/03/92 02/28/92 COMMENT OF DONOVAN A. SMITH, ESQ. CHP (
- 4)
- 1) 03/06/92 02/29/92 COMMENT OF OHIO CITIZENS FOR RESPONSIBLE ENEGY, INC (SUSAN L. HIATT) {
5}
03/C9Jt2 03/04/92 COMMENT OF THE QUAKER OATS COMPANY (NORMAN P. RUSSELL, P.E.) (
6}
03/09/92 03/05/92 COMMENT OF NRD INC. (J. DAVID MCGRAW) (
- 7) 03/09/92 03/06/92 COMMENT OF DONOVAN A. SMITH (
- 8) 03/11/92 03/10/92 COMMENT OF SOLON TECHNOLOGIES, INC.
(JEFFREY L. KENNEDY) (
9}
03/11/92 03/10/92 COMMENT OF MCDONNELL DOUGLAS CORPORATION (LISA R. JENKINS, RSO} (
- 10) 03/12/92 03/09/92 COMMENT OF OHMART CORPORATION {GEORGE W. BROWN) {
- 11) 03/12/92 03/05/92 COMMENT OF BERTHOLD SYSTEMS, INC. (G. M. SMITH, JR.) (
- 12) 03/12/92 03/11/92 COMMENT OF AMERSHAM CORPORATION (BYRAN W. BAKER, PH.D.} {
- 13) 03/13/92 03/12/92 COMMENT OF JAMES W. MALINOSKI (
- 14) 03/16/92 02/11/92 COMMENT OF JOHN W. GILCHRIST (
15}
DOCKET NO. PR-031, 032 (56FR67011)
DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 03/16/92 03/09/92 COMMENT OF JOHN R. DUKES, MANAGER (
- 16) 03/16/92 03/09/92 COMMENT OF ANN L. MORITS, OFFICE MANAGER (
- 17) 03/16/92 03/ 10/92 COMMENT OF BUREAU OF RADIATION CONTROL (DAVID K. LACKER) (
- 18) 03/16/92 03/ 11/92 COMMENT OF ISMA (WILLIAM HEGARTY) (
- 19) 03/16/92 03/11/92 LTR HEGARTY TO DSB REQUESTING AN EXTENSION TO THE COMMENT PERIOD OF 60 DAYS 03/16/92 03/11/92 COMMENT OF AIR TRANSPORT ASSOCIATION OF AMERICA (MIKE RIOUX) (
21}
03/ 19/92 02/28/92 COMMENT OF DONOVAN A. SMITH, ESQ. (
- 22) 03/27/92 03/24/92 COMMENT OF SELF-POWERED LIGHTING INC. (J. HENRIQUEZ) (
- 23) 03/27/92 03/25/92 COMMENT OF SRB TECHNOLOGIES, INC. (BRIAN G. PULLEN) (
- 24) 04/30/92 04/30/92 06/ 11/92 04/27/92 04/28/92 06/10/92 06/29/92 06/25/92 COMMENT OF ISOLITE CORPORATION (SANFORD B. WHITE) (
COMMENT OF SAFETY LIGHT CORPORATION (LARRY HARMON) (
LTR. PARLER, GC TO JAY SILBERG RESPONDING TO ATTACHED LETTER FROM SILBERG TO CHAIRMAN SELIN DATED 6/6/92 RESPONSE TO W.C. PARLER LTR OF 7/ 10/92
- 25)
- 26)
DOCKET NUMBER PR J I 3 2 PROPOSED RULE
,i (56 Ffl £?(!)// J SHAW, PITTMAN, POTTS & TRowB¥tf.Q~~
A PARTNERSHIP INCLUDING P ROF"ESSIONAL CO RPORATIONS 1501 F'ARM CREDIT DRIVE MCLEAN, VIRGINIA 22102 (703) 790-7900 F"ACSIMILE (703) 821*2397 JAY E. SILBERG, P.C.
(202) 663*8063 William C. Parler, Esq.
General Counsel 2300 N STREET, N. W, WASHINGTON, 0. C. 20037 (202) 663-8000 F"ACSIMILE (202) 663*8007 June 25, 1992 U.S. Nuclear Regulatory Commission Washington, DC 20555
Dear Mr. Parler:
- gz JUN 29 PS :1 2 01 LIBERTY STREET, S.W.
E ESl!IURG, VIRGINIA 2207!5 (703) 777*0004 METRO 478*8989 F"ACSIMILE (703) 777*9320 Your letter of June 10, 1992, suggested that my letter of June 6, 1992 to Chairman Selin might be misunderstood as seeking to influence the decision on the pending rulemaking to amend 10 CFR Parts 31 and 32 (56 Red. Reg. 67011) by communication outside the rulemaking record.
Needless to say, that was certainly not our intent.
We fully assumed that the June 6 letter and its attachments would be placed in the rulemaking docket as you have done.
We would request that this letter also be placed in the rulemaking docket.
(_ erelyk J y E ilberg ~
cc:
William Hegarty, President International Self-Luminous Manufacturers Association C. Richter White, President Isolite Corporation 0114:164j:s.92
Q\\'
CT OJ ARY SION D c*1r P I Stali.:.l;CS Postmark Date 6 / 'J..., /12-Co~es Rece~ed __
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Add I Copies Reproduced _-3 _ ___ _
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r I 1 E 1 JL (5 6 F 12. 6 7 0 I I UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 June 10, 1992 Jay E. Sil berg, Esquire Shaw, Pittman, Potts & Trowbridge 2300 N Street, NW.
Washington, DC 20037
Dear Mr. Silberg:
DOCKETED USNHC
- 92 JUN 11 P 2 :37 Chairman Selin has asked me to respond to your letter of June 6, 1992, concerning the Commission's pending rulemaking to amend 10 CFR Parts 31 and 32.
The NRC' s rulemaking proceedings fol l ow the procedures set forth in the Administrative Procedure Act.
The essence of that process is that the agency provides notice of its proposed rulemaking and invites public comments, which are placed on the public record.
The agency then makes its decision on the record in light of those comments.
We have consistently fol l owed that practice, and the NRC's success in having its rulemaking decisions upheld in court is in part testimony to our strict adherence to norms of procedural propriety.
Interested persons are of course at liberty to write to anyone they wish to regarding a pending NRC rulemaking.
However, to forward such a letter to the Commission for its consideration creates at least the appearance of attempting to influence the rulemaking decision by communications outside the rulemaking record.
To forestall any possible misunderstanding, we are therefore placing your l etter, with its attachments,. as well as this reply, in the rulemaking docket.
We encourage the submission of comments on pending rulemaking in the manner contemplated by the Administrative Procedure Act and our notice of pro_posed rulemaking.
s* ncerely, William c. Parler General Counsel
SHAW, PITTMAN, POTTS & TROWBRI DGE A PARTNERSHIP INCLUDING PAO,-ltSSIONAL CORPORATIONS 1501 F'4RM CRltDtT DRIVlt MCLltAN, VIRGINIA 22102 (7031790-7900 F'4CSIMILE (703) 821-2397 JAY E. SILBERG, P.C.
(202) 663-8063 The Honorable Ivan Selin Chairman 2300 N STREET, N. W.
WASHINGTON, 0. C. 20037 (2021 ee3-eooo F'4CSIMILE (202) ee3-eoo7 June 6, 1992 U.S. Nuclear Regulatory Commission Washington, D.C.
20555
Dear Dr. Selin:
201 Ll lt"TY STREttT, 5.W.
LEltS U"G, VIRGINIA 22075 (703) 777*000-&
'"l:TIOO *78* 9 9 F'4C51MILE (703) 777*9320 In connection with President Bush's initiatives on regula-tory review, I would like to call your attention to the enclosed letter to the Council on Competitiveness concerning the Commis-sion's pending rulemaking to amend 10 CFR Parts 31 and 32 (56 Fed. Reg. 67011).
The International Association of Self-Luminous Manufacturers and Isolite Corporation believe that the proposed rule as it applies to gaseous tritium light sources is not justi-fied by considerations of public health and safety.
In this con-text, I would also call your attention to alternatives which the Association has suggested to avoid the proposed rule's extremely adverse consequences.
These alternatives, which are set forth in the enclosed comments filed by the Association on the proposed rule, include treating self-luminous exit signs for buildings the same as signs for aircraft are now treated and providing to gen-eral licensees a "plain language" explanation of their responsi-bilities under Part 31.
trul~yo~
ilberg
)
cc:
William Hegarty, President, International Association of Self-Luminous Manufacturers C. Richter White, President, Isolite Corporation 6/8 **. To EDO for Appropriate Action... Cpys: OGC, DSB *** 92-0480
SHAW, PITTMAN, POTTS & TROWBRIDGE 1501,....... c*c01T 0lllfV~
MCl..C:AN. \\/UtGIHtA 22*0~
('703) 790*7900
.-.. cs,..,1.1:
(703) IIZl*Z397
..JAMES H. BURNLEY IV t202, ee3-9225 2300 N STl'IEET, N. W.
WAS H ING TON, 0. C. 20037 (Z0Z) 883*8000
" ACSIM H.£ (ZOZJ ISIS3*8007 May 15, 1992 The Honorable David M. McIntosh Assistant to the President for Domestic Policy and Director of the Council on Competitiveness Office of Domestic Policy & the Council on Competitiveness Room 286 17th Street & Pennsylvania Ave., N.W.
Washington, D.C.
20501
Dear Mr. McIntosh:
Z0I 1.1.l:fltTY ST*U:T, S #
1.1:1:s*u*G. 111*0,..,.. ZZ07S 17031 77'7*000.
,.CT-0 *'78*8989 l"ACSr*u1.&
(7031 T77*93ZO I want to bring to your attention a rule proposed by the Nuclear Regulatory Commission which appears to be completely con-trary to the letter and the spirit of the President's regulatory moratorium.
Our client Isolite Corporation sells and distributes self-luminous exit signs that contain tritium gas to produce light.
These signs are used because electric signs may be diffi -
cult to inatall and are le** reliable. Similar devices are widely used aboard commercial aircraft.
Because tritium is a
- byproduct material* (material made radioactive by exposure to radiation in nuclear reactors), it ia subject to licensing requirements of the Nuclear Regulatory Commiaaion.
For many years, the NRC'a reCJUlations have included *g-neral licenses* authorizing certain types of activities, devices and materials. Unlike *apecific licenses,* which require individual application and reviews by the NRC Staff, these general licenses are automatically available to anyone. :The reason for this dif-ferent treatment is that the NRC has found that authority granted by general licenses poses little risk to the public health and safety.
In December 1991, the NRC proposed to amend the general license authority for *certain measuring, gauging and controlling devices* (see enclosure).
The proposed rule* would add informa-tion gathering and reporting obligations baaed on the NRC's con-clusion that in a number of cases, some types of these devices have resulted in radiation exposure to the public, even though no
SHAW, PITTMAN, POTTS & TROWBRIDGE
& l"AIITNIII.IMI.. IMCLUDINCI.. 110, IIIOll&L C:Olll"OIIATIONI The Honorable David M. McIntosh May 15, 1992 Page 2 significant public health and safety hazards resulted from these incidents.
Although Isolite's self-luminous light sources are not *mea-suring, gauging [or] controlling devices,* they would neverthe-less be subject to the same new regulatory burdens.
The NRC pro-poses to subject self-luminous light sources to these new obliga-tions even though these devices have not been involved in any of the incidents identified by the NRC.
No cases have been identi-fied in which any radiation exposure to the public has occurred as a result of any incident involving these devices.
Notwith~tanding this safety record, and the lack of any jus-tification for imposing new regulations on self-luminous light sources, the NRC's proposed rule would add significant adminis-trative and record-keeping burdens both on the manufacturers of these devices, and more importantly on their users.
The NRC's estimates of the time and costs required to comply are totally unrealistic.
For example, NRC estimates it would only coat a general licensee 30 minutes to verify to the NRC:
Identification of specific information about the devices, such as manufacture, model number, number of devices, type of isotope, and who has performed what service on the device since the last report1 name, title, and telephone number of the person respon-sible for the device and for ensuring regulatory compliance, address where device is used, whether 10 specific requirement of NRC regulations have been met.
While these requirement in the abstract might be easy to meet, the cost for compliance multiplied by the very large number of these devices will likely put Iaolite out of business.
Where alternative devices are available that have no regulatory burdens and none of the associated costs, it is highly likely that the market for self-luminoua light sources -- and the $20 million in business that these sources produce -- will soon disappear.
If this were the price necessary to protect the public health and safety, the regulatory burden might be understandable.
But where the NRC has failed to identify any benefit to the public health and safety, the added regulations should not be issued.
SHAW, PITTMAN, POTTS & TROWBRIDGE 4 f'AIITNIIIINIP INCLUDINe PIIOPIIIIONAL COIIPOIIATIDNI The Honorable David M. McIntosh May 15, 1992 Page 3 Your assistance is appreciated to make sure that this unnec-essary, unjustified regulatory burden does not put Isolite and companies like it out of business.
We will be happy to supply any additional information you may desire.
cc:
bee:
Sincerely, J~nley James Gattuso (w/enclosure)
Jay Silberg
,. i Fedau Re9int1. Vol. 58. No. 149 I Frida?*, Dice-nber 2r.- 1991 / ~
Rulet l1'Cr.
- 4.
..1 Food Sat9ty and lnap * ~
S.. wtce On Sept.mber 24. 19'1. FSIS lica..;ed dnic:et a~ pnR'll&bly reduce published a pl"OpOMd nJe (51 FR 411J1) tlae potential for idcicMata that could I CAI hr1a 311 and *1 lo..ttNo.ll-033EI F1niehed Producta lnapK'tlan AOINC"t! Food Safety and Inspection Service, USDA.
ACTION: Proi,oted rule: reopenan, or comment period.
SU-A.-r. On September Z4. 19111, the Food Safety and Inspection Stmce (FSIS) publitbed
- proposed rule to amend the Federal mut and poulby productl inapectton replatioaa to allow caMiftl ntabliahmenta men lexibiltty in complyi,. With tha flll&latory requirements coac:erniDI ftntshed product inapecUon of thermally*
proceued shelf table canned product.
FSIS bat l'9Clived a raquat to atad the conunent period for u additional 30 daya. FSIS baa determiaed that die requnt should be snatecL ThtftfON.
FSIS is reopeatna the comment pertod for an additional 30 claya.
DATI: Comment, muat be received on or before: Januu, r:t, 1911.
AIION!- Written c:oaunenta to:
Policy Office. Attn: Ltnda Cany. FSIS Herinl Cltrk. room nn. Soutb Aartculturt BlatJdlq. Food Seftt, and ln1pectton Senic:e. U.S. Department of Acriculturt. Wathfna1oa. DC ZOZSO. Oral commentl II provided by the Paaltry Products lntpectton Act should be directed to Mr. WIIUam C. Smitb. at (20ZJ720-314CL flOII IIUll'TNlll -...aflON COlffACT:
Mr. William C. Smttb. Dlrwctar.
Proceued Producll lmpec:Uoa DIYiala&
Science and Tec:haoloo, Food Wac, and lnspecttoa Servtc:e. U.S. Departmat or A,riculturt. Wasbfnctoa. DC 20Z5G.
Area Code (ZOZI 720-3NIL Jaw: C 7.YY i111N BlitTIOIS Cumntly, quality c:CIGll8l,...._.
regardina finilhed pnNlaal lllnt*cti* of thennally-proceuecl lllillf mble cumed productl mutt comply_..,, r dflc requirementl of aectiaaa n&a Uld 381.308 of tht Federal... t and pou,llr)'
productl iupection repialicml,. The Agency received two pelitiam from tba National Food Proc:euon Attociatiaa (NFPA) to amend the Federu mat ud poultry praducta ia,..:Uoa nplattou to allow CUDial ***Ntabnwa** more laUtucla in complyu11 witb the requiNmeatl contaiatd ill ltdioU 31L30I and 31UOI of tbt Fedanl mat ind poultry producta inspecttoa N!l'll*tiou.
to amend l!1e Federal muat and poullr)'
result iD IIIIMCftMly radiation expMure produce, impection rtplatiou to allow to the public.
quality control Pf'OlrUll lo differ from D1**11n1 current replatory requiremeata. Such DA?U'" 3i & 11 period txpirn pro.,ams mu.at be determined to be Mm:11 tri* O>nunent1 rteeived l!quivalent to the curnnt reawatory after this data will be coaaidered if it is requinment1 or mtet the intant of such practicable c,, do so. but the NRC is able '
requirementl which la to provide to eillW"e cunsidfiratton only for assurance of Ult Nftty and atability of comments received oa or bef9re this caMed producta.
date.
lntertsted ptrlOCll were liven until ACDRPUH: 'fail writtea comments to November 25. 1911, to comment on tbia the Sec:ntary. U.S. Nuc!Hr Rt1ulatory propoeed rule. FSIS haa NCeived a Conuniuion. Waabinctoa. DC 20555.
requat to extend the comment period to AtttnUon: Doc.kttint and Service allow more time to review the propout Branch. Deliver c:ommtall to One White and submit COIIUNllta. n. A,eacy ia Flint North. 11551 Rockville Pike, interntad ln rec:eivtnt tuc:b informalioll RocnWe. MD, between 7:30 am and 4:15 pertainins to dlia propoaed rule and 6a.
pm on weekdays. ea,. of the draft therefore. '9CIP"i,. *ht c:oauMGt period
~torr w1ytg. u well u copies of for an additional 30 claya.
the c:onuneata rteltved
- the propoeed Done *t WubiJlatoa, DC. on: 0.C.lllba Z1.
1911...............
Acq Adtttinisll'OIOI'.
(Fil Dae. lt-31al Plied tz.ze-tt: 1:.S amf l&laaOOISII.....
NUCLIAII IIICIUU'TOIIY co*1111ou 10CPlt..... 11....
- 11* UN ftl~lr-afar.... llllllllP..
........ Dl'1HI *co111111111nt
..,..IIIN!,.. NudNr Replam17 ACl'IOllt Plupowd Nie.
srmn. Nudaar.......
Ccnrfatm (NllC) II PfGPIMNII IO UIIDdlla,.._.tloallO"ftlillldle*fe UM of byp,odMct Utena:I la Clllaill e
ea& ' urtbar, sptdftc Ucea1111 wbo ue dlstrtl,.to,,
of....U, lk:tutd dntcaa llDds 10 CPlt ft.I would be Nqllirld ID-*
IIDifona --* whea tublailtial die quutarly __,_ reports ID NIIC. n.
prapwd Nit la illlladtd IO rm dial
- IN Uma11n an**.,. of ud IUldaataad the raquirtmaDta,_ die pcMINlm of dtvtCN rmtaflltlle byproduct malenaL T1lfa aw.,..... will bettar.,...dlat----11.-c.a.- '"rill maply wtdl tba reqw--.zr.., f* p,apar handltaa wl diapoeal of.. neraU, nale, may be ualllintd at the NRC Public Documtat Rooa. Z1210 L Street NW. (Lower Level). Wallintton-DC.
,_ """""9 _,. Wt* CONTACT:
Jottpla J. Matt. Offlc:e of Nlldtar R.tuJato,y RNearcb. U.S. NudNI' Replatory Commlaaioll. Wuh!Jllton, DC WI. telephone (30II -.ms.
_,... 171'MY -.oMIATIOIC Oil February U.1951 (24 FR 1088). the Atomic F.ntf'u C,omei,aiOD amended its reaulatioaa to ptO¥idl *,-.ral Ucenae ror the UN of bJprodacl 1Ntarial coatalaed ill certaut la:tc-. measuring.
1aU1U11, and controWna clavicn. Under the c:umat requinmlata for poaeuion or....... Ucaut. c:ertaia penona may receift and l&N a device CODtainint byproduct matartal if die dnict b**
bee muufacbartd ud dittributed in ac:corduce wttll the apecillcationa contained ill a tplCi8c llclaM iuued by the NllC or by u A1r11 at 'State. A 1pectflc Uceue ii illUICI butd upon*
delenninatioa by* NPiatGIJ authority that tht uty,..... ol dllt devict and the inltncUou for* operation
.,....... and mNt raplatory requtnmanta. l'bt...,al llcanNe is requind to comply witla the tafety inatrucliou CODtaiaed ill or Nftrenced on the label of tlat device and to have the 181tfa1
- NfflC:illl ol tbe device performed by' u iDdmdual aulhorizecl to maaufac:tma. illlt&IL -
NfflC8 thnt devtae. A..-.U, llcaaad device is a "black box." lbat la. die nNINctive matanal
- contained ill a -led aource usually wttlMII * *t*lded clmce. The dnioe '8 dettpad wida inlltnnl radtadoll aaf.tlJ,_... N lbat it can be... br,.._. widl ao radiation trainfal*ex,-im. n.. tnt pnenl licenee policy ia *........._ to
'have been avoided. la addition. the
- 1implify the licen.N proceu to'that I caae-by<ae detarminatloa of lbe '
adequacy of the radiatiae traiDiq or experience of eacb'UHr la not nece11uy.
- tleanup coat were In excea of four niilllon dollara with additional co1t1 incurred for the 1taff eff oru of reswatory qeDCiet.
OilCU.._
There an about-* Siibk.iatt contain t.,,ilodw:t....Wfl _.,.
about 35.GOD Uoc1w _., lbe Cocnmteeion'I...-.1 llceaN ~tor)'
pr'Oll'lm. Ceneral licenlffl h1v1 not been contacted by NRC on a replar b11i1 becau1e of the relatively 1m.U radiation ritk poled by pnerally licented devices. TheN devtcn have 1urvived flret and explotioal on many occa1lona Without a total lou of 1bieldlq. They have been damqed by molten 1tNL and bit by coaatruction A
vebicln With only minor loan ill W radiation 1bieldint wbile maintainin8 the inteptty of the aource capaule.
Nonetbe(.... there ban been a number of occurNDCfl wben devtcet containint radioactive matari&l bave not been properly handled or dilpoNd of and rellllted ln radiation expoaure of the public. Nit=* ~!!!t '!!!L beclelt C
h /Aaillllllllllmllllll'm tMlll 111 st &LI. if proper IIIDdllns 111d d5" Dial procedurea bad beenfoirowed.
th... avoidable expoeurn would not have occurred. For txemple one or more cnium-type 1111181 wen mixed ln With tome ac:rap metal that wa1 melted down to form 1tael and the entire batcb of 1teel wu contamiDated. In another in1tance, a 1tatic ellmlnator bar with 22.5 millic:urtes of americ:iam-241 wa, A
1ent to a aanit1ry landfill over which the NRC h11 no jurladictton. There bave been other type* of lncideatl lnvolvtna NRC 1enerally licenaed dntc:n includina damqed devtces. lukint or contaminated aourcn. and equipment m1lfunctlona. However, loee of accountability, 11 occurred above.
rem1inl the moat frequent lnddent and the predominant concern.
BecauH of th... oc:curNDCel. the NRC'1 Office of Nuclear Matarial Safety and Safeguard, (NMSS) caadacted a radiological ri1k.......... addnlliq storage of deviCH in w...._
di1po11l in acrap yuda..-..Uon of wute. meltifts in *,melter. and d1apoeal in
- landfill. NMSS included In the rilk a1n11ment an incident 1t a 1tNI company in 1983 (dilCUlled in NUREG-1188. "The Auburn Stul Company Radioactive ContaminaUoa lnddent")
that probably repretentl a wont-cue 1cen1rio for.....,.Uy licamed IIUIUII device1. Althou,b individual dotn wen low and Within preec:rtbecl limit for expoaure of members of tbe public. lb-,
nevertbelNI reprnent unnecetlU)'
additional public expoture that could la comideration of both the ri1k aneument and lncidentl lib tho1e noted above. the NRC conducted
- three-year umplina (19N thru 1*) of general UceDlffl ( taken from the
- vendor'* quartariy reporta) to determine whether there w11 an ecceuntin, problem with pup UNn ander seneral liceua. and if to. what maedial action milbt be nec:euary. The wnplina w11 conducted both by telephone calla and 1ite mlta. The aampliq NVHled
- veral areu of concena reprdiq the UM of radioactive material under the
......i uceme provtaiou. On tbe buil of the NmPlinl-tbl NRC concluded that ia: (1) A lack of awarenna of appropriate replationa OD tbl part of the uer (pnen1 licn.tN) and (2) inadequate budll,. ud aCC011Dttna for th....--.UY liceued dmcn. The NRC further concluded tbat tbeN two problual could be remedied by more frequent and timely contact betwND the paenl bceuN and the NRC. Thia CODduton by tbe NRC pnmda the belie for tbe replatory cba..-
propoeed In this action.
AD Ntimatecl 70.000 AtrNIDlllt State liCIIIHII UN tbe tJ'PN of IOarCII and d"6c:el covtnd by the 1nMDdrnant1 beial PfOPONd today for tbt NJlC'a
.....,.i lk:eaaen. Comequeady, the
- Statee will play an imporWlt role iD ac:ldninl improved resulatorJ oventabt oa a aatiaaal balla. Muy of tbl Statn aJrudy bawe accoantabWty proarama In plw. n. Aanemmt Statee participated ID tbt davelopmllat of tbil na.le aad lndlcatecl qrNmnt wtth tbe caempt of tbe propoNd rule. Speci!lc ca mta froaa tbt :,:--t Statn
..,. adopted except or RIINtlona that tbe NRC c1wwe.. nenl licenNN fNe aad tbat then la no need for*
atandard format for aubmitttq illfanDadoa. n.. fN latut will be addnlNd eeparately. Tht propoted nale prcmdae ftmbWty ln the UM of the.,
ttudard formaL The Commtuion la conalderiq aaaklDt tbe amendment
- matter of compatibility for the Statn. The NRC 1taff bu auaatad that the amendment be catetari,led u OMIIOD 2 level of compatibWty. Thia level of compatibility requtne that Stattt addnae provtalona in NRC nplattona relattn, to balic pt'tlldplel of radlattoa aafttJ and l"lllllalGIJ flmct1oDI without neceuarily U1U11 ldaatical lanpqe. Stattt may alao adopt reqllinmenta mo,e restrictive than NIIC NIN ander tbit level of compatibility. The C'lmlllilsic:1 ¥*ou! j appreciate commentt oa thit *UGast.on.
Aft ntimated 35.GOO pertOftl UM certain mealurtnc, Plllinl-or controllt111 device, under the NRC.'s pneral licanae. NRC replation* that affect tbne.. neral licenNfl' responaibiliti.. and that an pretently beina amended IN 10 CFR 31.2. 31.4.
31.5. and 31.1. Under to CFR 31.Z.
Tenu and Conditiona." all seneral liCIDINS are 1ubject to certain proViliona of part 30 and alao parts 19.
ZO. and Zt. Tht propoaed revision to I 31.2 would allo 1ubject all pneral liceuen te tbe requirement, of 10 CFR 30.I. '"CompleteDIII and Accuracy of Information." which lmpoaea certain requinmenta resudlna the completeneu and accuracy of the Information 1ubmUted to tht NRC by 1Jcen1111 not now impoaed apon general
- lice11MN, Section 3'U of 10 Q'R part 31.
"laformatloa Collection Reqwnment1:
0MB approval." liata the YuiOUI NCUou of part 31 tbat contain apprond Information collection requinmenta. Parqrapb (b) of I 31.4 i1 beinl amended to add I 31.8 to the approved U.ttq.
Section 3LI. "Certam IDUlurinl, PIIIUII or coatroW,. devtc:a." providet f,-
- lfMRl liceDIN to 1cqwre.
recetva. poNII, UM. or tnntfer byproduct matariala. It a1,o 1pecifie1 the nspoulbilltiea or,.nera1 lic:emee1 reprd1q the ue of byproduct materiala. Under the propoeed revi1ion1
- new parqnpb (c)(lt) would be added to nquin tba sen*ral llceDSN to provide apec:iftc Information to the NRC upoa nquasL Thia information would Lnduda tba complete name and address:
apeciflc information about the device.
aacb u maauf1ctunr, model number.
and number of devict; namt. title. and telepboae number of tbe penoa rnpon1tble for coatrollina thf use of the devtce: the addrna where thf device is located,- UNd: and whether the 1peciftc requirement of pare,raph (cl of t 31.1 bave been meL In addition. a propoNd nvt1ion to parqraph (b) of I 31.1 would delete all referencet-to 1peciftc liceDHS illued by A8rffment Statn that authorise diatribution of devtcet to persona senerally licenaed by ApNment Statn.
The 1'91iatration and verification tyttem contained tn the propoeed amendment to 10 CFR part 31 and 32 will tndude all.....,.i lic:eDlffl.
iDcludlaa tboN wbo prevtouly acquired radtoactin aourcn. If older aourcn are tralllferNd. they would be aubttct to the NJDe requtrementl II UWtt IOW"CH and die,....tratiOD aylttm ii Intended i
i l
FedenJ R"littar / \\ -. ~. ~o. 2-49 / F:*iday. December 27. 1Jin / Proposed Rules 67011 tu capture them. CAnera* lice,11ee tran1fer1 of IOurcet are limited to either tran1fer to specific licenseu or other general licenlffl by the exi1tin, provisions of 10 CFR 3t.5(c) (8) and (9).
ln both cases. licensees muat notify the NRC of the transfers. 1C the specific licensee is a 10 CFR p*rt 3Z or Asreement State equivalent distributor.
the reportina requirements of the proposed rule would apply to any subsequent transfers. The current NRC data base. althoup lirnit!d, includet identification of general licennes who acquired 11auaes as early as 1959. The NRC staff plan* to -::ontact these licensees and any new pneral licer.see as part of the enhanced oversipt effort.
At present. 10 CFR 31.8. "General licen1e to inatall devicn 1enerally n1ed in I 31.5. provtd11 a aeneral n1t to certain 1pecific licen1eet from Agreement Statet to in1t1ll or 1ervice devicee used under I 31.S. The current rc"1!ation. 10 CFR 31.8. it not dear with rupect to time rutrtcttona. 10 CFR t50.20(b)(3), impote1 a 180-day*per-calendar-year limitation on the activities of Ap-tement State Licen1H1 in non-Agreement Statn. The propoNd amendmenta to I 31.1 would remove this re1triction for I 31.S ltc:ensen. Thi*
chan,e will be convenient to the NRC.
,. Apeement Statn. and manufactunrs I.
becauu it will reduce and 1tmpltfy piper work without increa1in, the ri1k to public health and Mfety. The propo11d I 31.e(a) would requin the itneral licentn boldffll 1 1pec:iftc licen1t from an Aanement State to a,ort to the NRC all persona receivina a
- vice from the licemN. 11 1pec:ifled ln the accompanyin, propoeed revision to I 32.SZ. Propoted I 31.l(d) wawd requin the licen,ee to 1upply **cb of the r,cipient1 of a aaerally Ucelllld davtce a copy of the.. neral licenM containad in I 31.5. PropoHCl I 31.l(e) would require that written inatructtou and precauti~n* be provided to penou sarvicina a aenerally llceued davtce.
Propo11d I 31.l(f) would alae nqutn a person perfonnilll routine....U.Uon/
servicing/relocation of tbae dntcea to r.otify the appropriate NRC...,,ad office at leHt 3 worki111 da,- pnor to the start of the activitin. n1a notification would allow for a level of periodic intpection of tho11 activitiet that intentionally place a worker In direct contact with the device or an unshielded radiation IOW'Ce. lt ia not intended that the prior natiftcation requirement apply in cua when 1 radiolo,ical buard due to an accident or a malfunction of the davtce exiata. To be con1i1tent with the propoeed modiftcaliona, the Mc:Uon be*dlq would be ame,aded to read "Cenerat licc?fth to distrfoute, inatall. and set'Vice
- device* ger.. raily licentad in I 31.5."
\\0 CFR 3~.511. "Same: Condition, of licenset," presently impo111 condition*
Cil' applicanta for a specific license to manufacture or initially transfer gt!nerally licenaeci device, to aeneral li.:en1H1, The addition or propo11d paraa,aph (c) to I 3Z.51a would require such specific licen1tt1 to provide recipient u1ers of pnerally licen1ed d11vic11 with written inttruction1 and precaution, to en1ure that the device*
are used 1afely. ln addition. theH specific licen1111 would be required to provide thoH u,en with infonnation regarding t11tin1 requirementa, transfer and reportin, requirementa. and dispotal options for the devicee beina tr1n1femd.
10 CFR 32.52. "Material tranafer reporta and recorda." currently require, specific licenaee1 authorized to di1tribute devtcn to pneral lfc:en1111 to file tnnafer reporta with the NRC OD I quarterty beat.. The NviHd rttulation would prelCfibe the format to be UHd when 1ubmittiq transfer reporia to the NRC. The propoHd format would provide more detailed and complete information about the paen1 lic:elllN to whom the device ii transferred. The format ii prneated in propoted aubpart E. I 32.310. Uc:emen who do not u11 the pmcribed format would be permitted to provide all of the information requirtd by the format on a clear and lestbl*
record. In addition. 1peciftc lic:eDH11 would be requincl to identify I penon reapouibl* for mNtin, the requiNmenta a110dattd with the po11111ioa of the...,.Uy UCIDHd dntc:e nthar tbu limply ldentifJinl 1 poilll of coatact at tbt.....,.i UC1111N'1 locatlo&
Alllr Ncetpt of the quarterly trauf*
repoltl tram tilt tpeciftc liCIDIN under 132.11. the NRC would NDd letten to the...... UcemNI who rec:etved the dfflCII durinl die p~tn1 l!'lpo,Una penod nqunttna diem to vent, In wrtttna that they bad purchaled tbt dmc:ee containinl byproduct material and that th-, undentand tba req11U'11119Dtl of the pura1 Uc:eDN. The 1...a Ucea.tN under propoaed I 3U(cK11)(UJ would be nquirtd to rnpoad to the NRC by letta, and to vertfJ llfety-nlated infonnation aboat the dnice and ill location. Thtnafttr, noticle would be Nllt pertodically to the punl Uc:ea11n nquatiat that th-,
vertfJ that the,,till have the device.
verifr the Hfety-Nlatad informattoa.
and remind them of their replatory rnpamtbillUn in 111in1 the device. Tht frequeac:y of tbeN letten may ran..
from 1 to 3 years. Any failure to respond or any reporta of 1011 devices would initiate NRC follow-up action. This
- contact between the NRC and the general licensn would allow the NRC to validate and update the information currently contained in the data base that the NRC maintain, for it1 1eneral licenaeee.
Altbouah th11e propoaed requirement, would impou additional cottt on licenne1. the Commi11ion has estimated the11 to be nominal (on the order of 110 per device). Accordin9ly.
the Commi11ion believes that the increased compliance by,.neral lic111HN and confidence in the approprtatene11 of the aeneral license propam potentially afforded by these new requiremenll outweia)l thia co1t.
Nonetbelftl. the Coauniuion particululy requ11t1 commenta on this matter.
At the time of the final rulemakins on thi1 matte,. the Commi11ion intend, to provide for an intertm enforcement policy to 1upplement the current Enforcement Policy in 10 en part z.
appendix C. to 1ddn11 violationa 1ri1iq from the propoaed replationa.
The interim policy would remain in effect for one cycle of the notice and retpODM prosram, approximately three yean. Under the ui1tin, NRC Enforcement Policy, 1ipillcant violationa 1uch H tho11 involviq lost 10un:n may rnult In ncalated action indudln, dvtl penalttea. The interim policy would provide that In the initial phaN of the implementation of I notice and retpoue prosram, enforcement actioa would not normally be taken for violatiou identifted by a liceDIN in 1ubautt1111 infonllltioa pumaant to the propoeed nswatton provided appropriate comctive action ia initiated. 11lia c:banp from the Cnmmtnioa'1 normal enforcement poUc:r ID 10 CFR put 2. appendtf C. i1 to rtmOft uay dilincentlve to identify deftdeadn c:aued by a c:oncem of poteatlal enforcement action. Thi*
actfoa would be taken to encourqe aeural licaaNI to Harcb their facil1tln to a11ure aourcn are located, to detename ti appllcable,equirementa have bNa met. and to denlop appntpriate cornctive action when deftdenda ve found. However.
ewarc:ement action will be colllidued far wtolatloa.l involvinl tbe failure to provide the informatloD reqae1ted or take appropriate conwctive action.a or willful Yioladonl indudfna tbe tublftittal of fa.lN information. Sactioaa in thoN 1ituatloaa may include ciwtl penaltin aa well u Olden to limit o, revoke the I
j
,..... Lfp,
, Vol SI. No. WI FriMy. D<<.cer.:bea ~1sm I PnpoHd.Rules WW WWW-
......._.__.Ill!,;~!!!!!!!!!!!!!!!!!!!!~
.,,, I I
C.L authprity, to paueu radioec:!iw aaurca unchr*IIDftUlk:aM-Ellv!rMn,etal -,.t: C..... k:al Exch*etae The NRC hat Jela'llliud that the piopo1ed rea*tiona.. the type of action dncribea in tbe cateeonc,al exc!u1ion 10 CFR 5U2{c)(3)(iii}.
Therefore, neitber an environmental impact 1tateme"t nor aa environmental asae11ment ba1 been prepared for tht1 propoaed repl1tfon.
Papeswadt Wwctia Act &&a..._.
The propoted nele amena the information collec:Uon reqwrementa that are 1ubject to the Paperwork lt.ducdoll Act of 1* (4f U.S.C. 3aot et Nq.). Thia propoeed rule bu bNII Abmittad lo tbe Office of Ma111nmt Uld Baqlt for review and aJIPfOftl of the papa wan reqllinmnta.
The public reportina burdan for tllia collection of informalioa is utimated to avera.. about 20 millutu per re1poua.
ir.cludiq time for N\\'iewq in1tructiona. 11arc:bkll exiltiq daaa IOW'CU. ptbertq ud maiAtaininl the data needed. and c:ompletiJla ud reviewiftl the collection of information.
Send commnta reprdiq tbil burdea e1timate or any otbar upec:t of this collectioD of information. includina l\\lllfltion1 for redudnl thil burden. to the Information and Recorda Mana.. ment Branda ~4), U.S.
Nuclear RIIUlatory Commiuion.
Waabiqton. DC 205II. and to the Dnk Officer. Office of Information and R91ulatory Aff1in. ~"EO~t. (3150-0019 and 3lliCMIOOI). Office of Mane1ement and Budpt. Wuldnstcm.
DC Z0503.
Replatory ADaly.
The !'.'RC hH pnpend a draft re,,,il!tory 1n1tl)*1is of thi1 propa11d l'el'Jlation. The analylia ellCUIUlft 1M coat and benefit of the altem1tiftt con1i.!ned by the NRC. 1'e draft anr.l;-sis it available far inapedlaa tn the !',RC Public Obc:u te* IOO& JUD L St~flt '.'.W. (Lt,wer IAftl). W.......
DC. Single copin of Illa draft ualyaa may te obtained from...... J. MAte.
Officer c,f Nuclear Repla.., llnevdl.
U.S. Nuclear Rqula~ Connntee'oa.
W,u.hin,tun. DC 20555. telephonr. 30l-492-3:"95.
R~tory f't*xibillty Certiftcatlaa B,.. ed on information available at thia
,t,ge of the rwemakint Proc:eedina ud in a:cordance with the Rtplatory F1e'llibility Act. 5 U.S.C. eo&(b). the NltC cer~ifiea that. if promwpttd. thia Nl*
w:il not have a 1ipiflcant economic imi;Jct on a '"l,11antial n11111ber ol ama1I entiti-. 11N NRC bu aaopt.cl *~
ltadmda that clallily a amail IIUity 11 one wboeearota um.al l'tceis,tl cio not exceecl SU lllilllon over a 3-ynr period.
Tbe prGpQIN Nie affectl 1bo1;t 35.000 penoaa uailll producta uder tbia
.. neral UCUN. many ol wbom would be cia11ilecl U a tmail atity. HOWHU, the NRC believtt tbat the ec:onomi&.
impact of the propoaed nquirementa on any.....-alUcaaNewollldbe nqlistble. TIie propoMCl nue ii bema iuuai ID belt* euure that the 1eneral liceDNtt andemaDcl and comply with replato,y lftpomibllWn np,dma &be
.. narally licenNd radioactive devicn in their poNIHion.
Bac:ldllADllylll The NJlC bu detenllintd thet tha backfit ru1a. 10 01l 50.tOt. doea not apply to thtte propoeed rwn and thenfon a backfit analyli1 la not requind bKauM lbNe propoaed 1mandmen*1 do IIOl involve any provilioal drat would impoM beddltl 11 ddDtd in to Q'lt 50.t.Oll(a)(l}.
LIil.,.., ** 111:
10CFRParl31 Byproduct materiaL Criminal penaltiN. Labebnt, Nacltar material-.
Pacbtial and coatainen. Radiation plVIKtiGa. ltepordne ad ncordknptna rtqlUl9mllltl. ud Sdentiftc tquipmenL lOCnlPanJZ Bypn,dact material Criminal penaltlel. LabeUna, Nuclear material-.
RadlatlaD pratectloa. Repor1iq and rec:orclbepins nquirnlentl, and Sc:leatilc equipmmt.
For die....., Nt oat In the p,..._ ucl uader die aatbority of the Aaa.ic IDftv Act of 19M. t1 amended.
tbe...., Reorpniulinn Act of 1114.
u marhd. ad I u.s.c. au. the NRC it PfDPOlbll to adopl die followtns
.,,.,,._.. to 10 CFR p1rt1,1 and u.
ltAIIT tt-GIIIIIIAL D0111ST1C UCll 1111 POil lYPIIOOUCT IIATIIUL
- 1. ne authority citation for pan '1 ii rtYiNCl to read u follow:
/\\rtt I J* S.:.. n. tn. 113. *Stat.mt.
Ml. IN. u 1 ID Mi (U U.S.C. %111. Din.
2m):..., JOI. *amwd:ld. 21aZ. M Stet.
lZU. u --dad. lJM tU IJ.S.C. Mil. 5612).
5ec:UoD JU a!IO iNuad undu NC. Z7f. 73 Stet.* ca u.s.c. 2DZ1J.
Po, die pvpoeee of NC. m. 111 Stet. 151. 11 ameaclld 1a u.s.c. unt: 1131.51c,t1HJJ and (SH.,, SU. 31.l(c). SUO(bJ. ud St.lt(bJ.
(CJ. ud (dJ.,...._. ander eec.111b. M Stat..._ u **W (fl U.S.C. UIJl(b): ud It n.s (c)(fl, (S).,.,. ud (11), 31.1 (dHf).
and 3t.11(bl ud (*l.,. iaaued and*r NC.
1110.
- Scat. 8IICL II amended (4% u.s.c.
Z2i>l(oJ;.
- 2. Section 31.Z ia reviled to read as folluwt:
I SU T._ INIC..... -.
The..-,.11icenHI provided in this put are 1ubjec:t to tbe provision of II 30.I. 3CL14{d}. 30.34(1) to (e}. 30.41.
30.51 to 30.13. and partl lt. 20. and 21 or thi1 cl:aptar a Ullln1 indicated otherwise in the lupqe of the senenl licenae.
- 3. ID I 31.4 parasnpb (b} i1 reV11ed to read ** follows:
I SU 1nroma1ar lolKtlon
,..._. Olla IIIPl'OWL (b) The approved information colltctiOD requiremeatl contained in this put appear in H 31.5. 3t.e. 31.8. and 31.11.
- 4. ID I 31.J, parasnph (b) i1 revt1ed and puqrapb (c)(ll) ii added to read
- foDOWI:
fUI C...111
--*or (b} The StDenil liceDN ill parqraph (a} of lhi HCtion appU.. only to byproduct material contained In devices that bave bNa &D&Dufactwed or initially traDlfmed and labtltd in accordance wttb the tpteiftcatiou contained in
- 1pedftc UcenN iuutd punuant to I 32.51 of 1h11 chapter or lo accoraance wttb the pecificatiolLI contained in the
,.nera1 licenN of I 31.1.
(c) * * *
(lt) Shall respond within 30 calendar dap of receipt of a request from the NudNr.....,..,011 Comnuuion to verify the followiq information and ar,y otbar tucb infonnalloo ** may be reca-ttd bJ the Commi11ion 11,t relatn to the..-nl liceDN. Further.
tha..-,al licelllff,ball notify the Dittctor of Nudear Maten* Sef~ty ancJ Safepatdt. U.S. Nudaar R.acuiat~ry ColllllliNion. Walbinttoa DC 2C!55 within 30 calend.tr day* ii any of the requested information 1buuld change.
(I) Name and e<1mplete addn11 of the aenenl Uctnee.
(ii) Identification of specific infonnation about the device. 1uc.h 111:
the manufacturer. model number. the
- Al1ftttclll II diNCtN puttaiar!J to the
~
......... ~.,.., **, 111..
cbaJta IMI........ *DaU:11 °' COllleinera.
- ~
~ 1 rr 1111 ltr,nduct aiatenai ia dniml__,*..-1 ~
111 I JU before
,.....,,11. ttn....,-to~-* o:
bWWIJ._--ilila..... _
_,dl ltle labelilll ~
- .r,f I n.1
- effec1 ca lanu ry lt. tr.I.
WWW 1-*....-1 Relit* i wol. S& No.-24.9 / Fiid1y, J)ecember ~. tw1 / Proposed RwH I
67015 -
- r. 1mb1r of devicn. t~ of ilotope, and who has perfonntd wnat Nl'Yic:e on the d<!Vice,in~ tht la1t report collCfflWll the de\\ ice wa1 submitted to the NRC.
liiil Name. title. and telephone number c.f the pel'!on who is re1po111ible for the device.tnd for en1urin9 compliance with the appropli1cte rqulationa and.
requirement,.
(i\\*) Addre1.1 at which the device 11 l*Jcated or us'!d.
(vi Whether the requirement* of i 31.5(cl(1) tholltb (c)(10) have been met.
- 5. Section 3U i1 amended by revi1iq the aer.tlon headins and the introductory par111rapb and by addinc parqnpba (a).
td), (e), and (f) to read aa followt:
A31.10....__1oc1111...._......,
fJU.
Any person who holda a 1peciflc licen11 by an Aartemeat State authorizint the bolder to manufacture.
cii1tribute. inltail. or Hrvic:e dmcn described in I 31.5 within the Ap'lement State ii hereby aruted
- seneral licenN to di1tribut1. inltall. or service the dnica in any non-All'ffmtnt State for an unlimited period of time and 1...,.i lic:enN to di1tribute. inltail. or Nrvtce the devicn in off1hore watan. H deftned in I 150.3(0, provided that (a) Th* Aarttment State UcenaN flln the appropriate tnmfer reportl H required by parqrapba (a) and (b) of I 32.52.
- (di The per10,:1ball 0
fumiaha copy of the 1eneral lic:tnN containad Ill I 31.5 of thi1 chepter to eacb penon who ia reaponaible for the byproduct mataial and for enaurial compllaaca with die
.ppropriate reswattona and requirementl.
( e) Th* penoa,ball provida die individual reapouibl* for Nf¥tce of die device with wntten inltructlom aad precaution, nec:aaary to.... itl Ml*
1n1tallation. operation. amillrftC&
These in1U'uctiona,hall blclllde lNk*
resun, requinmenta. ~aad reportina requU'tlllenll. dllPONI option,. indudint potlible caet8 aad reportin1 reqlliremenll for loet or damased dtvieet.
( 0 Th* penoa perfonninl routine Hrvice/in1tallation or relocation of devic11 shall notify the appropriate NRC Rtlional Office li~ted in Appendq D of part 20 of thit chapter.at le11t 3 wortdns
,day* prior to en,qina in 111cb activitiet, in Non*A,r'elment Sta.te. The "otification shall include the date and location of the activity that will be performed. Prior notification dou not apply in caae1 where I radlolopcal hazard due to an accident or malfultction of the device exi1ts.
I PART 32-INCIPIC DOIIUTIC UCINSU TO IIANUPACTUM OR TRANSFIII CIRTAIN ITI**
CONTAINING IYPIIOOUCT IIATEIIIM.
- e. Th* authority citation for part 3Z continun to reed a1 followa:
Audlentr, Sect. n. 111. ta. ta.
- SlaL as. NIL 153. IM. u amended (41 u.s.c. nu.
2201. Z232. ZZU): NC. 2111, 11 SlaL 1ZU. u
-~
(41 u.s.c. 5M11, For the,..,,_.. of NC. m.
- SlaL ti& u amended (42 U.S.C. ZZ73J: II 3Z.1S. 31.11 (a).
(cl, and (di, U.11. u.zs la) and (bl, 31.21 (aJ and (b). 3Ut. JUI (al, (b). and (dJ. u.a JUI, 3Z.II. and azto IN leeaed uderNC.
111b. II Stat. NIL u ameedld (41 U.S.C. Z2Dl
(!:>IJ: and It 3Z.1Z, 3Z.tl. 3UD. 3Z.21(cl, 32.21(c). u.s1a. 3Z.5Z. u.a and u.no.,.
iuued under NC. ttto. N SlaL 1111 U amaadecl (41 U.S.C. mt(o)J.
- 7. Section 3Z.5ta la amended bJ addlna parqrapla (c) to read u follows
,......... c........... *.
(c) Furnitb the indlvtduala identdlecl under I 31.5(c)(1t) or I 31.l(d) wttb written in1tructtoaa and precaalione nace11uy to t111UN aafe tutalladoa.
opentioa. and lll'Vice of the clmciL TheN inltrudiom mut include Iba ltak-tNtiaa Nqainmnll. trallw ud r-,ortlnlnqaiwnll. di.,_.I opdont incladiaa pollible cottl. a.i,.,...
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(a) Report quartarly to the 0inctal',.,
the Offlc:e of Nadar Matenal Salee, and Saf..... U.S. Nuclnr......,_,
Commieeioa. Wubiqton. DC 20IIII.
and NDd a copy of the report to tbe apprapriata NRC reaioaal office l1ttad la appeadbc D of part 20 of thll cbapte all tranafen of 1udl devic:n to pel'NM,-
use under the.. nenl liceDN in I 31.5 of thi1 chapter. The raport m111t be provided either in the format pruented in 1ubpart B. I 32.310. '"Trenafer Report Format." or on a clnr and leaible record 11 10111 H all of the date required by the format it included. If one or more intermediate penona temponnly POIIIIHI tbe device at lht intended place of UN prior to itl poallUion by the uer. the report muat include the same information for eacb intermediary H in eubpart B. I 3Z.310. and clearly duipate that penoa II an intermediary. If no tranafen have been mada to penona.....,.Uy lic:enaed under I 31.S dllfint the N1Nl'tilll period.
the report m111t to indicate. The report mut cover tach c:aJendar quutar end mut be filed within 30 clap of the end of tbe calendar quarter.
(b) Report quartarly to the mpomible ApNmeat State 11111CJ all tranafen of 1ucll daYicu to penou for uae under a alMnl UCIILN ill U Ap11 -~ State,
,.a.ttou that an equmlent to t 31.5.
11le report mut be proyided either in the format in aubput E. I u.no.
Tramfer Report Format." or oa a dear and laaible record ** lone u all of die data requind by tbe format.. included.
If one or more iDtanudlate penom tamponrtly POHHW tbe device at the lntmdld plact ol UN prtor 10 Ile poe1111ioa bJ tbe UNI', the report must include the.... Information for tach inl8llllecliarJ u in eabpart I. I 3Z.3to.
111d clearly detipata that penoa H an intarmediarJ. If DO traDlfffl bave been made to penom.....,.uy Uceutd unc1ar 1 31.5 dunna the Nportina period
- tbe report mat* indlclte. Th* report mut cover acll caleadar qautet and mut be filed within 30 clap of the end of tbe caleadar qauW.
(cl IC-, NCOlda of all trllllfen of
... clntcN forNda...-.a liceUN and la oompllaac1 'Wida the above repmttna requinmlDta of I 3Z.5Z.
Recardl requind bf dUI IIClkll muat be maintaiMd for a period of 5 yean from the data of the recorded ewnL
- t. Subpart B. I 3U10 ii added to 10 CFR part 3Z to,.ad u followa:
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Tbfa MCtioa CODtaina the format requindbyfUU.
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- Subpart E-Report of Transfe.r ~t Bypro~uct Materials Section 3'2.310 - Transfer Report Format l
NAME OF VENUOR AND LICENSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE INFORMATION COMPANY NAME. STREET. CITY, DEPARTMENT STATE. ZIP CODE C>ERSON RESPONSIBLE FOR CONTROL OF THE DEVICE NAME ANO TITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY ANO UNITS NUMBER NUMBER I:
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shutdown.
DATU: Comfflentl ffl1lllt be Ha**
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Con lnttrNted perlOU are lDviteci 10 p&rtiapa&eintumuialal..
propoaed rule by 1ubmittiftl 1ucb IIWritttaMIII. Yin& *....... ti U they may dnin. Commllllicatioaa 1hould identify the NtUlatory docket number ud be *bmitted ia tripUcate IO the addna 11pec;fted *....._ All rnr,mpppj('4tjou rem!... 08 or before the doainl date for commea,, eptei8td 1bove. will be c:ouidel'N before tulnt acUOD OD lb* propoMd Nie. n.
propeeaia v*wd.Isl tlai9.,_--,
be chanaed In Upt of tbe comment.I receiveQ.
Commeatl.,. 1pec:iflcally Invited oa t.'11 ownll NtUlatorJ, tcOOUillk:.
enviroamataL and aerv aapacu of the propoaed Nie. All cammeatl
,ubmitted will be aftilable. botb before and altar die ~*-for cnNnll, in die llaaiN Doc:bt fm U*INt:loa bJ inttnlted.,_.... A report daat 1WIIIUrisN NCb FM-,ubllc contact conc:eraed _.. tbe ftbal*a*-af thil propoeal will be ftJed In die Rulel DocbL ADJ,.._-, Gbtaia
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1911. in order to auun the airworthimu ol thNe up&an. in C.nada. The airplanet.,.
manafac:tand in Caawda Ind are type certificated for opention in the United Stalls. Punuaa& to a W....a
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TIie PM hu uuliMd tlae lacllq1 of Tl'8111p81t Caneda. rme..t.U available lnfonnadon. and determined thatADac:16all-1 IIJ'Wproducta of du1 type dnip that arw......_
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SHIELD SOURCE INCORPORATED March 11, 1992 The Secretary U.S. Nuclear Regulatory Commission Washington, DC 30555 Att: Docketing and Service Branch Re: Proposed Rulemaking: 10CFR Parts 31 and 32:
Federal Register Vol 26 No 249 Page 67011:
Requirements for the Possession of Industrial Devices Containing Byeproduct Material.
Gentlemen:
This comment is submitted on behalf of the International Association of Self-Luminous Manufacturers (ISMA). The membership includes all manufacturers of Gaseous Tritium Light Sources (GTLS) in North America and overseas.
Negative Impacts Compliance with the proposed changes will increase the amount of paperwork and administrative time required by both general licensees and regulatory agencies. The NRC and Agreement States propose to contact all general licensees directly, to verify information contained in quarterly reports submitted by specific licensees, and to ensure *that copies of regulations supplied have been read and understood. Essentially, this duplicates procedures already in place. Furthermore, it has been proposed by Agreement States that the NRC should charge fees to general licensees to cover the costs of these additional procedures. Recent experience has proven that such fees will cause users to cease using radioluminous products, and switch to non-regulated alternates.
In its proposal, the NRC confirms that after investigating all incidents of misuse or improper disposal of generally licensed products, "no significant public health ~nd safety hazards resulted from these incidents.* ". Some smal l radiation exposures occurred, but even in the worst case scenario.. "individual doses were low and within prescribed limits for exposure of members of the public ** "
We note that in these examples of public radiation exposure, gaseous tritium sources and devices (GTLS) are not mentioned. In our view, the risk to the general public from GTLS under normal and severe conditions of use is far less than that of the products mentioned in the examples, which as stated, have never exposed the public to more than a small fraction of prescribed limits.
Route 2 Box 19C VFW Road, Grasonville, MO 21638
The Secretary, USNRC Comments on Proposed Rulemaking Page 2 March 11, 1992 GTLS products have been distributed worldwide to commercial and industrial general licensees since the early sixties. In the United States, GTLS industrial and aircraft emergency exit signs have been sold in production quantities for twenty five years or more. The total devices used, including those now disposed of, is estimated in the millions. Yet we know of no single instance in which a member of the public has ever been exposed to radiation from these devices which could possibly be considered hazardous to health.
These factors suggest that the potential cost and market impact of these proposals are not justified based on the anticipated safety benefits. In particular, the risk to the public from self-luminous emergency exit signs is far outweighed by the known benefit to life safety in building fires that is provided by these reliable products.
By the NRC's own estimate, the cost of instituting the proposals will cost six million dollars, affecting 35,000 general licensees.
No cost impact to specific licensees is given, although increased costs will certainly occur.
Since the general licensee cost impact is based on $10 per device, those using larger quantities of devices will be disproportionately affected. Significantly -higher costs will apply to users of self-luminous exit signs than, for example, users of beta gauges or other instruments which have higher unit value and are purchased in much smaller quantities per location.
The NRC's estimate of cost impact of $10 per device is underestimated. A typical licensee will spend a great deal more than $10 per device to complete all research and paperwork required, verify installation locations, verify receipts, confirm understanding of safety instructions, provide product and contact information, and then respond in writing. In any event, the administrative costs are only a part of the total impact on users, which must include the intangible factor. of resistance to perceived unecessary paperwork, and non-productive time.
Recent experience of actual cases arising from increased regulatory requirements by some states, and/or fees charged to general licensees, has proven beyond doubt that users of self-luminous exit signs will regard additional regulatory procedures as too costly to justify continued use of the products. They have replaced GTLS devices with electrical devices, which use more energy, cost more to operate, do not offer the reliability of GTLS, but require no such administrative cost. We already know of a number of cases in which the licensee has simply cancelled orders and discontinued use
The Secretary, USNRC Comments on Proposed Rulemaking Page 3 March 11, 1992 of GTLS products, rather than comply with regulatory procedures which are perceived as burdensome.
The proposal to introduce fees to general licensee will increase negative reactions by users of GTLS exit signs. Some states have already introduced fees, which has and will continue to cause loss of business for our members. Even if increased paperwork and administrative costs are accepted, we have found that licensees will reject the payment of any fees for an emergency lighting device and will replace the product with competing electrical signs.
If implemented as proposed, we believe the net economic effect of these proposals could be extremely severe for the GTLS industry, in which emergency exit signs contribute a large fraction of total revenues. The total potential cost impact is estimated at more than
$20 million per year in lost revenues, with associated substantial loss of employment. Such a loss could easily result in the demise of the industry itself.
Finally, the cost to taxpayers cannot be ignored. The NRC proposes to contact in writing and/or by telephone all 35,000 past and present general licensees, for verifications of receipt, transfers, safety instructions, understanding of the regulations, responsible persons, product locations, etc. In our view, this process will result in large government costs out of proportion to the small safety benefits that may result.
Proposals for Revisions to Part 31 The inclusion of gaseous tritium luminous devices in section 31.5 as part of "Certain Measuring, Gauging or Controlling Devices" has implied to specific and general licensees that a similar level of risk applies to all products covered in the section, and that similar regulatory control procedures are justified. We do not agree with this view. There are fundamental differences between GTLS luminous products, and "Measuring, Gauging or Controlling Devices", which difference is in fact implied by the title of the section. They include potential radiation risk, cost per device, typical quantity per site location, and others. A large portion of the section concerning testing for radiation leakage is not applicable to GTLS devices. General licensees are often confused by the overall complexity of the present section 31.5.
In order to help general licensees more clearly understand their obligations specified in 31.5, we propose that specific licensees include a "plain language" interpretation of the regulations in
The Secretary, USNRC Page 4 March 11, 1992 Comments on Proposed Rulemaking each device package. This would be accompanied, as presently required, by a copy of the general license and a statement of the associated Agreement State regulations.
For the past nearly thirty years, GTLS manufacturers have been distributing self-luminous safety devices for use in aircraft containing tritium gas, under specific licenses issued per Section 31.53, to general licensees under section 31.7. Tritium light sources for aircraft signs are manufactured from identical materials as those in commercial exit signs.
We propose that luminous exit signs for buildings be separated from section 31.5 and either included in section 31.7 of the regulations, together with luminous signs for aircraft, or covered in a new section, 31. 8. The building signs would continue to be manufactured under a specific license issued under section 31.51.
The reporting, labelling and propotype testing reuirements would therefore be unchanged from the existing regulations.
Summary of Comments
- 1.
The proposed changes will cause burdensome extra paperwork and administrative costs for manufacturers, general licensees and regulatory agencies.
- 2.
The potential total cost impact and negative market impact are not justified compared to the anticipated safety benefits.
3.
The total cost and customer resistance impacts of full implementation of these proposals to the GTLS industry is estimated at more than $20 million per year in lost revenues,
with a concurrent risk of liquidation of the entire industry.
- 4.
A large portion of section 31.5 concerning testing for radiation leakage is ~ot applicable to GTLS devices. General licensees are often confused by the complexity of section 31.5, and do not understand "*the important paragraphs.
- 5.
Radiation risk to the public from ge~erally licensed devices has been stated by NRC to be very low. No member of the public has ever been exposed to more than a small fraction of prescribed limits. Risk from gaseous tritium products is even l ower than the examples cited, and is outweighed by the known benefits of safety to life offered by these products.
The Secretary, USNRC Page 5 March 11, 1992 Comments on Proposed Rulemaking
- 6.
Users of self-luminous exit signs will regard additional regulatory procedures as too costly to justify continued use of the products. They will replace GTLS with electrical signs,
which use more energy, cost more to operate and do not offer the reliability of GTLS, but require no such administrative cost.
Proposals A
- Luminous exit signs for buildings to be separated from section 31.5 and either included in section 31.7 of the regulations, together with luminous signs for aircraft, or covered in a new section, 31.8.
A new title for 31.7 is proposed as:
"Luminous safety devices for use in aircraft and commercial buildings".
B.
With the exception of the proposal above, section 31.5 is adequate and should not be changed.
- c.
Present requirements of 31.51 for manufacture and distribution of GTLS safety signs are adequate and should not be changed.
D.
The *present reporting requirements for GTLS safety signs under 31.Sl(a) are adequate and should not be changed.
E.
Each specific licensee should include a "plain language" interpretation of thd regulations in each device package distributed to general licensees. This would be in addition to a copy of the general license and a statement of the associated Agreement State regulations.
F.
Fees should not be charged by NRC or Agreement States to general licensees for, the use of GTLS safety signs in commercial buildings.
Very truly yours, WiY!~<i~~y President, ;~~~
cc: ISMA Members Jay Silberg Esq: Shaw, Pittman
4150-A OLD BERWICK ROAD, BLOOMSBURG. PA 17815 717-784-4344 FAX 717-784-1402 28 April 1992 The Secretary U.S. Nuclear Regulatory Commission Washington D.C.
20555 ATTN: Docketing & Service Branch t ~)CKETEO USNRC
- 92 nPR 30 P 3 :53 RE: Proposed Rulemaking:
10 CFR Parts 31 & 32; Federal Register Vol. 26, No. 249, Page 67011; Requirements for the Possession of Industrial Devices Containing Byproduct Material.
Gentlemen:
Safety Light Corporation has been distributing aircraft placards and commercial exit signs since the early 1970's.
Both of these devices use the same gaseous tritium light sources (GTLS).
Both types of these devices must undergo rigorous prototype testing per 10 CFR before the manufacturer can receive a specific license to manufacture and distribute these devices.
It has been Safety Light Corporation's experience that there has only been one or two incidents regarding commercial exit signs and none, to my knowledge, involving aircraft placards.
Indeed the discussion section of the above Federal Register does not even mention commercial exit signs.
The discussion goes on to say that a "three year sampling" was "to determine whether there was an accounting problem with gauge users".
The reason for mentioning aircraft placards in my opening statement was to agree and show support with Shield Source Inc., letter to the Secretary dated 11 March 1992, where in Will Hegarty makes a case for a new section in 10 CFR for commercial exit signs only.
Both the aircraft placards and commercial exit signs are used similarly to show means of egress.
The only difference being that one is used in an aircraft and the other is used in a building.
Measuring, gauging and controlling devices are different than commercial exit signs.
Commercial exit signs are installed in buildings under various codes.
Once the signs are installed, they are not moved from location to location nor do they represent a portable use.
/... Continued
- r.
'- I
SAFETY LIGHT C ORPORATION U.S. Nuclear Regulatory Commission Docketing & Service Branch 28 April 1992 Page 2 It is my opinion that the present quarterly reports that specific licensees and licensed distributors are required to send to the USNRC and 'Agreement State licensing boards are sufficient to determine the site location of the devices.
If it has been found that general licensees that possess commercial exit signs do not understand their obligations as general licensees, I feel it is because of all the wording that is now required for specific licensees to supply to general licensees that have to do mainly with measuring, gauging and controlling devices that confuse the general licensees.
In conjunction with having a new section in 10 CFR for commercial exit signs, I suggest clear, precise, to the point language in layman's terms should be included with the shipments to the end users.
The following wording is suggested:
This document is to be given to and kept on file by the End User.
Upon receipt of these commercial exit signs, you become a General Licensee with certain obligations to the USNRC.
They are as follows:
- 1. The End User must know location of and account for all exit signs in the building.
- 2. If a sign is missing from one of the above locations, it must be reported to either the USNRC region that deals with your state or the licensing board of an Agreement State. (Agreement State locations, addresses and telephone numbers along with the USNRC region locations, addresses and telephone numbers are attached to this document.)
- 3. Disposal instructions for disposal of this product is located on the USNRC label which is permanently attached to the sign.
If in doubt, contact the USNRC Regional Office or Agreement State Licensing Board listed in #2 above.
/... Continued
/JUL 15 l'39Z Acknowledged by card............................... _
SAFETY LIGHT CORPORATION U.S. Nuclear Regulatory Commisssion Docketing and Service Branch 28 April 1992 Page 2 It is Safety Light Corporation's opinion that the above will accomplish what the USNRC wants to accomplish for commercial exit signs.
The cost to the End Users and the taxpayers and the resultant loss of business to licensed commercial exit sign manufacturers is less than ethical by the USNRC when all that is necessary is simplification of general licensees'responsibilities in regard to commercial exit signs.
Very truly yours, SAFETY LIGH CORPORATION
~SOLITE DOCK~T NUMBER PR F'ROPC r, RULE
'2> / 31-( 5" t Ffl 61011)
- 31 Waterloo Avenue
- Berwyn
- 19312 * (2..J3:ijfIDl7-8200
- Fax (215) 296-8953 April 27, 1992 The Secretary U.S. Nuclear Regulatory Commission Washington, DC 30555 Attn:
Docketing and Service Branch
'92 APR 30 P2 :50 Re:
Proposed Rulemaking:
10CFR Parts 31 and 32:
Federal Register Vol 26 No. 249 Page 67011:
Requirements for the Possession of Industrial Devices Containing By-product Material.
Gentlemen:
I have been the National Sales Manager for Isolite Corporation since 1984.
We have been selling and successfully distributing these products for many years, and there has never been a case of personal injury due to contamination of tritium gas.
As a matter of fact, since I have been associated with this industry for the last eight years, there have only been two cases of tube breakage.
In both cases the end user followed the instructions that they were given for proper disposal and for replacement with new signs.
We at Isolite have been very careful to never send out a product without full information on where it will be used.
This information is submitted quarterly to the proper states and authorities.
The system has worked well, the building industry has come to rely on this product as a safe, economical and dependable exit sign.
Personnel within the building industry, as well as the local fire inspectors, are fully aware of the general licensing and the procedures to follow once it is time to return the product to the manufacturer for replacement.
If, as has been proposed, the NRC or individual states would charge a fee to have this product, the sales, in my estimation, would drop dramatically.
The consequences of this would be that the companies now manufacturing these products, for both commercial use and the airlines, would cease to exist.
A kn JUL 1 s ms,;--
c owtedged by card................... :... :.::::; *
,;-"t :- *\\, '\\
I LI I J-f-/ q 2-
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";/ *-
Apri l 27, 1992 Page 2 The lighting industry would then become void of a source to purchase this product, as well as a source to return the old products for proper disposal and replacement of new.
At the present time, this procedure is being conducted within the self-luminous industry in a proper and orderly manner and is economical to the end user.
It is not costing the taxpayer a cent.
If by charging a licensing fee which results in the demise of a viable industry, the NRC or individual states would then be required to dispose of exiting signs when they mature without providing new products in their place.
This will cost the taxpayers a great deal of money for disposal, as well as the end user having to wire the building in order to put in the standard electrical exit sign.
There is no good reason for any of this to happen.
The self-luminous exit sign has proven to be a safe and reliable product causing no harm to personnel or the environment.
Please leave it alone!
SBW:cc
SRB Technologies, Inc.
P.O. Box 25267 Winston-Salem, NC 271 14-5267 Tel: (919) 659-2610 FAX: (919) 768-7720 March 25, 1992 The Secretary U.S. Nuclear Regulatory Commission Washington DC 30555 Attn: Docketing and Service Branch Gentlemen:
ouCKET NUMBER PR 3 / 3 ::2_
PROPOSED RULE (!'1, ft: (1._i)
"'O(; i:. H:.0 USNRC
'92 MAR 27 A10 :56 Ref: Proposed rulemaking: 10CFR Parts 31 and 32:
Federal Register Vol 26 No 249 Page 67011:
Requirements for the Possession of Industrial Devices Containing Byproduct Material.
I must stongly protest to the above proposed rulemaking. As a manufacturer of Gaseous Tritium Light Sources and Devices (GTLS & GTLD) this proposal has the potential to destroy not only my business, but that of other manufacturers and the numerous service industries which support this market.
The proposed changes will increase the amount of paperwork and administrative time required by both the general licensees and regulatory agencies. The changes only serve to duplicate the procedures already in place.
It has also been proposed that the NRC should charge fees to cover the cost of these additional procedures. Similar fees have already been introduced in some states and we have already seen users cancelling orders and switching to non-regulated products rather than comply with the procedures. These changes are perceived as an extra burden at a cost far in excess of those figures estimated by the RC. We have no doubt that this additional cost to existing and future users of self-luminous exit signs will result in the demise of the self-luminous industry in the United States.
It is our view that the NRC is over reacting by classifying all general licensees with the same conditions. We note that in the examples of public radiation exposure, GTLD's were not mentioned. The risk to the general public from GTLD's is far less than that of the products mentioned in your examples. In fact, the NRC's own proposal states that in incidents of misuse or improper disposal of generally licensed products, "no significant public health and safety hazards resulted from these incidents.. " and "individual doses were low and within prescribed limits for exposure of members of the public.. "
APR 1 5 \\992 Acknowledged by card............... NHtlK&H.....
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Comments on Proposed Rulemaking Cont'd...........
March 25, 1992 GTLD's have been used worldwide for the past 30 years. In the United States GTLD's have been used for more than 25 years in such life saving devices as industrial and aircraft exit signs. Over the years many hundreds of thousands of GTLD's have been used and yet we do not know of one instance where a member of the public has been exposed to radiation from these products which could be considered hazardous to their health.
With the above facts in mind we feel the potential cost and market impact of the proposals are not justified. The benefits of ownership of our self-luminous products in terms of saving lives due to their inherent reliability far outweighs the extreme low risk to the public.
Finally, I am appalled at the potential cost of such an exercise, with the NRC proposing to contact over 30,000 general licensees. It is our view that this cost cannot be justified by the small safety benefits that may result from a product that has an excellent safety record over the past 30 years.
Proposals for Revisions to Part 31 It is our view that self-luminous exit signs be seperated from Section 31.5 of the regulations and included in section 31.7 along with aircraft exit signs. Section 31.5 implies that a similar level of risk applies to all products covered in this section. This is not the case.
There are many differences between self-luminous products and "Measuring, Gauging or Controlling Devices", including potential radiation risks. An example is that self-luminous devices do not require leak testing.
Truly yours,
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Brian G. Pull;
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President
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SELF-POWERED LIGHTING C:
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8 WESTCHESTER PLAZA, ELMSFORD NY 10523 TEL. 914 592 8230
- TELEX 131639 The Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch LLGhi:. if:f_*
- 92 HAR 27 AlO :S6 March 24, 1992 RE:
Proposed Rulemaking: Federal Register Vol. 56 No.249, Page 6711
Dear Sir /Madam:
We hereby respectfully submit our protest to the subject proposed rulemaking.
We find the proposal to be totally insensitive to the disastrous impact it will have on our industry. Preliminary indications from the few states who have introduced fees to general licensees strongly support our co~tention. Simply stated, customers who wert! aF.ected, immediately canceled all existing orders for self luminous emergency exit signs and changed specifications to insure that the product would never be used again.
Triggered by similar customer complaints one of our major national distributor decided to discontinue the sale of our products.
We will be glad to furnish copies of pertinent correspondence upon request.
Based on the above it is clear that the six million dollars cost to implement the ruling would eventually be a total waste of the taxpayer's dollars since it will simply deter customers from using the product to begin with and thus eliminate the need for the rulemaking in the first place.
Moreover, the reason for even proposing to implement such a ruling is not clear since we know of no incident during the past twenty five years in which a member of the public might have been exposed to radiation anywhere even approaching the maximum limit from broken or defective radioluminous exit signs. On the contrary we know of many instances where lives might have been saved had self-luminous exit signs been used instead of non-functioning electrical exit signs.
JH/67 APR 15 l99Z ~
Acknowledged by card................. mm,,.,
Member: National Association of Manufacturers* Chamber of Commerce of the United States* National Fire Protection Association
U.S. NUCLEAR REGULATORY COMMISSIO~ 1 DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date 3
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I As a founding member of the International Self Luminous Manufacturers Association we strongly support the comments submitted by the Association on their correspondence of March 11, 1992 and fully agree with their proposals.
Further, we request that the proposed rulemaking be applicable only to devices with potential radiation and/ or a history of risk to the general public. This is certainly not the case with self luminous emergency signage containing tritium which has been rigorously tested under American National Standard N540-1975 Classification Designation T5GC1333X3 prior to licensing for distribution to the general public.
JH/gjt cc: ISMA Rep.
JH/68 Sincerely,
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J. Henriquez President
DOCKET NUMBER PROPOSED RULE PR 3 I 1 ~ ~
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February 28, 1992
'92 MAR 19 A 9 :31 Information and Records Management Branch (MNBB-7714)
U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Gentlemen:
This concerns the proposed amendments to 10 CFR Parts 31 and 32 as published 12/27/91 at 56 FR 67011; in particular, your estimate of the reporting burden for collection of information.
I believe that your estimate of 20 minutes per response is unrealistically low.
Even an estimate of one hour may be overly optimistic because of the need to maintain records of responsible individuals; develop and confirm in writing an understanding of NRC regulations; check the device; read instructions and complete a questionnaire; affix the signature of an individual authorized to act for the general licensee; and dispatch the questionnaire after making file copies.
Later there may be time spent in follow-up actions if the NRC's records do not agree with the general licensee's records.
It is noted that your Paperwork Reduction Act Statement does not comment on proposed new recordkeeping requirements for distributors of devices.
Was this burden considered?
As a consultant to companies authorized to distribute devices used under 10 CFR 31.5, I am pleased to have this opportunity to comment.
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Donovan A. S~Esq. CHP 4821 Bel Pre Road Rockville, MD 20853
U.S. NUCLi:AH REGULATORY COMMISSIOr.
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E.I. DU PONT DE NEMOURS & CO. (INC.)
MEDICAL PRODUCTS DEPARTMENT DOCKE TED
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- 92 MAR 17 P 4 :14 Secretary of the Commission
,- r~*,r ~ ";:- ('.,cp-i f, !"March 10, 1992 u.s. Nuclear Regulatory Commis~*~
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Washington D.C. 20555
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Attention:
Reference:
Docketing and service Branch.
Proposed Rule "Requirements for the Possession of Industrial Devices Containing Byproduct Material" Federal Register/Vol. 56 No. 249/ Friday, December 27 1991. Page 67011.
Dear Mr. Chilk:
These comments are submitted on behalf of the Boston Area Manufacturing Division, Medical Products, E.I. Dupont de Nemours and Company. This division is a global supplier of devices containing byproduct material and the proposed rule is therefore relevant to our operations.
We recognize that the intent of the proposed rule is to address loss of accountability by general licensees and the improper disposal of byproduct material contained in devices.
We empathize with the USNRCs concerned for the small but unnecessary public exposure that could potentially result from such improper disposal.
It appears that the potential for public exposure is very small, certainly the collective dose could only be a tiny fraction of the dose from natural radiation sources. It seems too that the proposed rule, referenced above, will cost society about eighteen million dollars a year to implement.
We conclude that the cost to society cannot be justified by the tiny reductions in dose that might be achieved.
We strongly recommend that the USNRC publishes a cost benefit analysis and use the results of this to justify any further regulatory actions.
We appreciate the opportunity to comment, please contact the undersigned if you have any questions.
Yours sincerely, Leonard R. smith Radiation Protection consultant MEDICAL PRODUCTS DEPARTMENT 549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595 Fax (617) 542-8468 APR 15 1992 Acknowledged by card................................,,.
U.S. NUCLEAR REGULATORY COMMISSIO~
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E.I. DU PONT DE NEMOURS & CO. (INC.)
MEDICAL PRODUCTS DEPARTMENT Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.
20555 Attention:
Docking and Service Branch.
March 6, 1992
Reference:
"Compatibility of Agreement States Programs with NRC Regulatory Programs" Federal Register/Vol. 56, No. 246/Monday, December 23, 1991.
Page 66456.
Dear Mr. Chilk:
These comments are submitted on behalf of the Boston Area Manufacturing Division, Medical Products, E. I. Dupont de Nemours and Company and DuPont Merck Pharmaceutical Company.
DuPont Boston Area Manufacturing Division is a major supplier of radiochemicals for biomedical and l ife science research applications.
DuPont Merck is a major manufacturer and distributor of radiopharmaceuticals for nuclear medicine applications.
The above referenced subject is highl y relevant to manufacturers and to our customers.
The Agreement State program provides a degree of uniformity that ensures that hospitals and life science research establishments safely obtain by-product radioactive materials for their needs which are of immensurable benefit to society.
Unfortunately the same provisions do not apply to accelerator produced radioactive materials.
Instead these are subject to a multitude of conflicting regulations that vary considerably from state to state.
Non uniform regulations threaten to jeopardize the availability of sealed sources used in nuclear medicine.
Suppliers expend considerable resources in addressing the varied terminology and requirements used in different states.
Overcoming these difficulties inevitably involves costs that affect the costs of healthcare and life science research.
We are concerned that differences in state and local regulations are often due to political considerations.
We would prefer that all regulations for controlling radioactive materials be based on the best possible safety and protection criteria.
Furthermore, we believe that, standards, requirements and terminology should be strictly uniform to prevent costly duplication of licensee and regulatory effort and to avoid the potential for confusion.
MEDICAL PRODUCTS DEPARTMENT 549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595 Fax (61 7) 542-8468
- Consequently we strongly recommend that the NRC works closely with the States to establish and maintain uniform regulations founded on international scientific safety and protection consensus.
If you have any questions concerning these comments please contact the undersigned.
Thank you for the opportunity to comment.
Leonard R. Smith Radiation Protection Consultant
COMMENTS ON "THE COMPATIBILITY OF AGREEMENT STATES PROGRAMS 'WITH NRC REGULATORY PROGRAMS"
- 1.
As noted above, Congress established the Agreement State program in part because of the various and conflicting programs being implemented by States.
Do you believe that there should be a uniform national approach to radiation safety natters? Should the scope of uniformity be narrowly focused or comprehensive? Please explain the advantages and disadvantages of views expressed.
International, NRC and State regulations for the safe handling of radioactive materials should be uniform.
There should not be different safety standards for by-product and accelerator produced radionuclides.
Regulatory standards, t erminology and requirements should be comprehensively uniform.
Uniform regulations eliminates unfair competitive advantages to manufacturers, allows for optimization of resources, eliminates confusion to licensees who distribute to many States and countries, eliminates duplication of regulatory effort, eliminates the need to retrain radiation protection staff and radioactive materials users who are hired from out-of-State, prevents confusion in liability cases, and reduces the cost to society of research and healthcare.
- 2.
As indicated in the description of the four Divisions for compatibility decisions on regulations, compatibility can be implemented in a tiered manner, with the ranging from being identical to complete Agreement State Flexibility.
- a.
Is the tiered approach described in the Divisions a reasonable approach for regulations? For programs as a whole?
The tiered approach of the NRC appears appropriate and reasonable.
- b.
What areas of Agreement State radiation control and protection should be identical to those of the NRC and why?
All standards, terminology and regulatory requirements should be identical for similar reason given above.
This is particularly important for areas of radiation protection and control that concern individual dose and the transfer of radioactive materials for use or disposal.
The primary purpose for recommending uniform standards is to ensure continued protection and safety of licensee employees and the public.
Although radiation protection controls are well understood by licensee and regulatory professionals, the general public lacks this knowledge and is often unaware of the high safety standards that prevail.
Public perception could be expected to deteriorate further if there were numerous standards and it appeared that the regulators did not know which standard was appropriate.
- c.
What areas of Agreement State radiation control and protection should be allowed to be different from those of the NRC and Why?
Should the differences include: more stringent standards, less stringent standards, more comprehensive requirements? Please explain the basis for your views.
In general, standards shoul d be identical to those based on international consensus achieved by international experts.
The development of standards should reflect the best continuous review of scientific data, technical capability and licensee practice. It is inconceivable that a State or local regulatory agency can serve the level of expertise necessary to develop independent standards.
A possibl e exception to strict uniformity should be considered where it can be shown that local safety conditions are substantiall y different from those used in establishing national standards.
The goal should be optimum standards, uniformity with federal and international regulations being an important element of the optimization process.
- 3.
What mechanisms should the NRC use to allow Agreement States to have flexibility to address local needs or conditions? What factors should the Commission consider in balancing local needs or conditions and interstate or international commerce concerns or other national interests?
The NRC should require Agreement States to provide justification for proposed regulatory variances to address local conditions.
Justification must be primarily based on safety and control.
The primary factor that the NRC should consider in addressing interstate, international and other national concerns is to what extent lack of uniformity will compromise safety, regulatory compliance, professional control and knowledge, and consistency.
Another consideration should be the cost of non-uniform regulations, particularly how it affects the quality of healthcare.
The NRC should allow Agreement States flexibility in implementing the regulations.
- 4.
Should Agreement States be given a greater degree of flexibility in fashioning their own standards for low-level waste disposal, in view of the State's increased responsibility in this area, according to the low-level Radioactivity Waste Policy Amendments Act of 1985?
Standards for low level waste disposal should be nationally uniform where possible.
This is necessary since the future location of disposal sites and configuration of compacts cannot be predicted.
Waste generators have to establish facilities, equipment, procedures and skills to prepare waste to meet specific standards for temporary storage, transport and disposal.
A variety of regulations will cause some generators to reprocess waste with potential for unnecessary exposure due to doubl e handling.
- 5.
Provided the issue of compatibility is fully aired in rulemaking notices, is the current comment process sufficient for continuing dialogues with those persons outside the NRG/Agreement State regulatory partnership? If not, what alternative would you suggest and why?
All licensees and relevant regulatory agencies should be involved in developing uniform regulations.
The current comment process is useful in involving licensees, however, all relevant regulatory agencies should be formally involved in the process.
There is a need for regulatory agencies to agree on limiting and clarifying their areas of jurisdiction to prevent conflicting and duplicative regulations.
Developments should involve all agencies in all forms of radioactive materials and ionizing radiation including accelerator produced, by-product, naturally occurring and discrete and diffuse sources.
6.
Should the NRC develop exemption criteria for an Agreement State that does not adopt a rule deemed a matter of compatibility, as described for NRC' Division 1 and 2 rules, if an Agreement State requests such an exemption?
What Factors should be considered in the criteria to assure that the exemption is justified?
Generally the NRG should not grant exemptions for Agreement States to criteria in Division 1 and 2.
On a case-by-case basis the NRG might grant a variance if the Agreement State can demonstrate substantially different local conditions.
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oF AMe~~j-0 The Secretary U.S. Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, DC 20555
~c?;h~n 8g~o~~il;~~l~~AR 16 A10 :31 Phone (202) 626-4000
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March 11, 1992ooc'KE1iNG '* SEiN ICL GRI\\NCH
SUBJECT:
Requirements for the Possession of Industrial Devices Containing Byproduct Material-NRC Proposed Rule Ref:
RIN 3150- AD34 Gentlemen:
The Air Transport Association of America (ATA) submits the following comments on behalf of its member air carriers. Under the definitions provided in the proposed rule, ATA members would be considered users (general licensees) of a number of the subject industrial devices. Our members use isotope devices in radiography inspections. Sealed radioactive devices such as luminous emergency exit signs and radioactive sensors used in aircraft indication and communication systems, are also installed and maintained on commercial aircraft operated by our members. Collectively these devices number in the thousands. ATA was advised by NRC staff that aircraft smoke detectors and counterbalance weights would not be subject to the provisions of the proposed rule.
ATA members support regulations which would mandate that manufacturers and distributors (specific licensees) identify the users and provide users with training materials so that proper handling and accounting procedures are implemented.
ATA members object to the proposed rule because it would require that users track the subject devices through various phases of usage. Members particularly object to proposed Section 31.5 (c) 11 which requires that general licensees notify the NRC within 30 days whenever any of the requested information changes. ATA members indicate that aircraft luminous signs and tritium gages are not now individually serialized and are found in numerous locations on each aircraft. Collectively ATA members operate over 4,000 aircraft and routinely replace such devices at hundreds of station within the United States and elsewhere. The provision as presently written, would also require users to report each time a new device is received. Adoption of this provision would require operators to implement elaborate and costly tracking procedures.
Acknowledged b car APR 1 5 1992 y d "'"""""'""'"""""
tJ.S. NLJCLEAR REGULATORY COMMISSIOI'-.
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The applicability phrase found within the Section 31. 6 is confusing.
ATA interprets the proposed provision as applicable to general licensees who may resell the subject devices and in the process, become "specific licensees".
Particularly confusing is the use of the word "install". ATA members routinely install the subject devices and consider themselves as general licensees. If section 31.6(f) were applicable to their operations, then they would be faced with a nearly impossible administrative task of notifying the NRC at least 3 working days prior to whenever any such devices are installed or relocated.
The cost impact analysis provided in the supplementary information for the proposed rule is inadequate.
It is a gross oversimplification to estimate that projected costs to adopt the proposed rule would amount to $10.00 per device. Our objections relating to the adoption of Sections 31.5 and 31.6 alluded to the implementation of elaborate procedures for tracking each of the devices. There would be costs incurred initially in establishing tracking methods, equipment acquisition and/or increases in production personnel and sustaining costs in maintaining records and reporting. Such costs certainly do not equate to $10.00 per device. ATA would estimate that its members alone would spend several million dollars to implement the proposed rule.
Under the Presidential regulatory moratorium that is in effect, the NRC is under the obligation to ask itself whether this proposed rule will achieve its regulatory goals at the lowest possible cost to the regulated community. ATA submits that the proposed rule fails to meet this test.
ATA therefore requests that the proposed rule be withdrawn and that a supplemental notice be drafted which considers a more cost effective approach to addressing concerns over disposal of radioactive devices.
ATA suggests that a rule be proposed which provides a market incentives for compliance. The specific licensees could offer a rebate to the general licensees to return used devices.
One of our members proposed that this NPRM be rewritten to focus on tracking general licensee procedures for handling the subject devices instead of tracking each individual device.
Attached are the individual comments of the ATA members on this subject. Your consideration of their comments is appreciated.
Attachment DL/ cc:
Selected E&M Exec.
Sincerely, Mike Riou
- Director, Airworthiness & Engineering
A.C>ELTA AIR LINES,INC:.
GENERAL OFFICES HARTSFIELD ATLANTA INTERNATIONAL AIRPORT ATLANTA, GEORGIA 30320-6001 U. S. A.
Mr. David W. Lotterer Director Airworthiness and Technical Standards Air Transport Association of America 1709 New York Avenue, N.W.
Washington, D.C.
20006 March 4, 1992
Subject:
Requirements for the Possession of Industrial Devices Containing Byproduct Material - NRC Proposed Rule
Reference:
Miscellaneous Memo 92-10 Engineering & Maintenance Executives Wire 2/21/92A
Dear Dave:
The referenced memo advises that the NRC is processing a proposed rule which, if adopted, would require general licensees who possess the subject devices to provide the NRC information about identification of such devices and about the people responsible for such devices.
This information would be reported quarterly.
The referenced wire provides additional information regarding specific devices which the proposed rule would address.
We have reviewed the proposed rule, and have the following comments to offer.
As stated in the "Summary" of the proposed rule, the intent of the proposed rule is "to ensure that general licensees are aware of and understand the requirements for the possession of devices containing byproduct material", and to "better assure that general licensees will comply with the requirements for proper handling and disposal of generally licensed devices... ".
We believe the intent of the proposed rule will be reached far more readily and quickly if the rule were rewritten to focus on tracking general licensee procedures for handling the subject devices, instead of attempting to track each individual device used by a general licensee.
In the proposed rule, the NRC estimates that approximately 600,000 of the subject devices are in use by approximately 35,000 general licensees; it would be substantially easier to monitor the 35,000 licensees than to track each of the 600,000 devices individually.
Specifically, if the NRC required information from each general licensee indicating: that they were aware of and understood the requirements for the possession of each type of subject device they hold; and, that they had procedures in place to ensure the proper handling and disposal of each type of subject device, such information would negate the need for tracking and reporting the status of each individual device.
Appropriate procedures for a particular type of device would provide the same level of safety, regardless of the number of that device a licensee possesses.
Further reports would be required only if: a licensee acquired a new type of subject device that the licensee did not have procedures in place to assure proper handling of that type of device; or, if the licensee elected to change those procedures.
Mr. Dave Lotterer Page 2 March 4, 1992 If the NRG refuses to modify the proposed rule to require information regarding each general licensee's procedures for handling the subject devices, and requires information regarding each individual device, we wish to make the following comments.
The proposed rule would affect Delta's use of luminous (self-illuminating) emergency exit signs and escape slide pull handles, B-757/B-767 fuel quantity gauges, L-1011 counterbalance weights, certain thickness gauges, and possibly, smoke detectors.
The rule would apply to specific licensees and general licensees, although different actions would be required of the two licensees.
For the sake of clarity, it would be desirable to define "specific licensees" as manufacturers of the subject devices, and "general licensees" as the users of the subject devices, in the text of the proposed rule.
Paragraph 31.6(f) of the proposed rule would, "require a person performing routine installation/servicing/relocation of these devices to notify the appropriate NRG regional office at least 3 working days prior to the start of the activities" [underlining added].
Theoretically, this would require Delta (as a general licensee) to notify the NRG, 3 days in advance, anytime we replace or relocate luminous emergency exit signs or escape slide pull handles, certain fuel gauges, or counterbalance weights.
Since these activities are routinely conducted during maintenance visits, on a nearly daily basis, it would be impossible to comply with the three day notification requirement without severely impacting our operations.
While we believe the intent of paragraph 31.6(f) is to apply only to the specific licensee, this paragraph is not clear enough to avoid possible misinterpretation.
Therefore, we suggest 31.6(f) be rewritten to, "require a specific licensee performing routine installation/servicing/relocation of these devices to notify the appropriate NRG regional office at least 3 working days prior to the start of the activities".
Paragraph 31.S(c)(ll) would require general licensees to respond to NRG requests to verify certain information (contained in sections (i)-(v) of this part); in addition, general licensees would be required to notify the NRG if any of the information listed in sections (i)-(v) should change.
Sections (i)-(v) include information such as, "identification of specific information about the device, such as:... the number of devices" [section (ii)] and, "the address at which the device is located or use" [section (iv)].
Since Delta uses the subject devices on hundreds of aircraft, in various applications on those aircraft, such as signs, gauges, and counterbalance weights, and since the devices are not individually serialized, individually tracked, parts, literal compliance with these requirements will be impossible.
Furthermore, we would be required to note when, "the number of devices" changes.
This requirement will require a report each time we receive a new device.
Compliance with this regulation would be unrealistically burdensome.
Mr. David Lotterer Page 3 March 4, 1992 As written, the proposed rule does not indicate what, if any, devices might be exempted.
Assuming no exemptions, Delta will be required to register each device with the NRC, and maintain records from purchase to disposal for each device.
Based on the proposed nominal fee of $10.00 per device, and depending on the final wording of the regulation, the proposed rule could cost the airlines millions of dollars in registration fees and recordkeeping requirements.
In summary, Delta notes the following:
- the method the NRC has chosen to meet the intent of the proposed rule, which will require tracking each individual subject device, may not be the best manner in which to accomplish the stated intent;
- a different method of meeting the stated intent, in which general licensees report the following information to the NRC:
(a) the different types of subject devices the licensees hold; (b) that the licensees are aware of and understand the requirements for the possession of each type of device; (c) the licensee's procedures to ensure proper handling and disposal of each type of subject device; will be substantially easier to implement and less costly; If the NRC will not change the proposed rule as noted above, then the following deficiencies in the proposed r ule should be noted:
- the terms "specific licensee" and "general licensee" should be explicitly defined;
- paragraph 3l.6(f) should be clarified to indicate that it is applicable only to specific licensees;
- the requirements of paragraph 31.S(c)(ll), sections (i)-(v), may be unreal istically burdensome at best, and logistically impossible at worst.
Sincerely,
~~~
Russell H. Heil Senior Vice President Technical Operations
USAir February 21, 1992 Mr. Dave Lotterer Director - Airworthiness and Tech Standards AIR TRANSPORT ASSOCIATION OF AMERICA 1709 New York Avenue, NW Washington, DC 20006
Dear Mr. Lotterer:
In response to Miscellaneous Memorandum No. 92-10, Requirements for the Possession of Industrial Devices Containing By Product Material -
NRC Proposed Rule, USAir is adamantly opposed to this proposed rule.
We currently possess several items which could be covered under this proposal.
These items are emergency exit signs on all aircraft, fuel quantity indicating systems on Boeing 757 and 767 aircraft and counter weights used on control surfaces of most aircraft.
If each of these items must be accounted for and licensed separately, it would be an undue burden on the operator in terms of both financial as well as the record keeping aspect.
Due to the fact that there has been no major incidences involving these devices, we feel that this proposed rule is unjustified at this time.
RJJ/cm cc:
M.
R.
R.
J.
Cohen Weatherbee Radzanowski Kania Russell J. Jones Inspection Foreman - NDT
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NORTHWEST AIRLINES St. Paul MN 55111-30)14 Karch 2, 1992 Subjcat1 ATA Memo ~2-10
- Dave, Here are a few quick co11111Hmt1a on this 1 te.m:
(1)
NWA reels it is the 111anufaeturar'R r@RpnnRihility tn report or record trdnsre1: ur Lhetse ltemts l.u lhe NRC.
(2)
NWA i5 licensed only for the isotopes used in inspections of aircraft.
We do not have saepa;fate lieonsos for depleted uranium or exit signs.
I suspect these items are licensed by the aanufact.urer and come to us as a "par:kFHJA rlA~.l" with the aircraft purohasQ.
(3)
The logisticR nf thi,; undert.aking would probably requira a full time a~tiign.ment for this additional record kaoping.
(4)
NWA returns all of these items to the OEM.
If thoro exists a case where tnese items are disposed of elsewhere, then and only then, do I thinK we need to raport these activities.
Sorry for the late response.
Call me if you have any questions.
Jeff Register
SOUTHWEST February 27, 1992 Mr. Dave Lotterer 1709 New York Avenue, NW Washington, DC 20006-5206 REF: Letter Miscellaneous Memo No. 92-1 0
Dear Mr. Lotterer,
SOUTHWEST AIRLINES CO.
General Office P.O. Box 36611 Dallas, Texas 75235-1611 (214) 904-4000 In response to the referenced letter, we submit the following information for your consideration.
Southwest Airlines will be impacted by this rule. Our aircraft are equipped with three different types of luminous emergency exit signs and a number of our aircraft are equipped with Jamco Ionization type smoke detectors. Our control surface counter balance weights will also be affected by the rule. This untimely rule will add another hardship to the airlines in these most difficult times. The devices mentioned in this letter should not be included in the proposed rule.
Thank you in advance for your time and consideration in this matter.
Sincerely,
_/49/~
Stan Williams Director Quality Control/Reliability
/cg
AmericanAirlines MAINTENANCE & ENGINEERING CENTER David Letterer Director - Airworthiness and Technical Standards Air Transport Association of America 1709 New York Avenue, NW Washington, DC 20006-5206 REF: Miscellaneous Memorandum No. 92-10 2/20/92
SUBJECT:
Requirements for the Possession of Industrial Devices Containing Byproduct material -
NRC Proposed Rule
Dear David:
Items currently manufactured and sold under the General Domestic Licenses include Smoke Detectors, Gages, Certain measuring, gauging or controlling devices, certain HF electronic devices and Luminous safety devices for use in aircraft.
The proposed regulation is an effort to register all such byproduct materials and devices.
This proposal would require the licensee to supply each of the recipients of a generally licensed device a copy of the general license contained in Title 10, part 31.5.
Proposed 31.6<e> would require that written instructions and precautions be provided to persons servicing a
generally licensed device.
Proposed 31.6(f) would also require a person performing routine installation/servicing/relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to the start of the activities.
This notification would allow for a level of periodic inspection of those activities that intentional ly place a worker in direct contact with the device or an unshielded radiation source.
As written, this proposed regulation does not indicate what might be exempted.
Mr. Joseph J. Mate, NRC Representative handling this proposed rule, indicates that it is not their intention to register items by serial number.
However, assuming nothing is exempted, that means that all Luminous Exit Signs, 767 /757 Fuel Quantity Gages, DC-10 Counter Balance Weights, Thickness Gages, etc. would have to be registered with the NRC and records maintained from purchase to disposal.
MD PO BOX 582809 TULSA. OKLAHOMA 7 4158-2809. CABLE ADDRESS AMAIR
The proposed nominal £ee has been estimated to be $10 per device.
Depending on £inal wording 0£ the regulation, this could cost the airlines millions 0£ dollars in registration £ees and record keeping.
The NRC estimates there are about 600,000 devices that c onta in byproduct material in use by about 35,000 licensees under the Commission's general license regulatory program.
As stated by the NRC, no significant public health and safety h~zards resulted from incidents involving byproduct material. The recommendation must be to make no changes in the current program.
I£ it has been working this successful all these years it must be a good program.
cc:
C.H. Eads D.P. Huffman P.O. Wilson Sincerely,
~'2,1,J, /J#~-~-uf&-
Burl W. Nethercutt Radiation Safety Officer
E&M Exec. Wire 2/21/92A
Subject:
Requirements for the Possession of Industrial Devices Containing Byproduct Material-NRC Proposed Rule Ref:
Misc. Memo 92-10 The ref. memo included a proposed rule from the Nuclear Regulatory Commission which if adopted, would require users of the subject devices to provide the NRC, information about receiving such devices, assurances on proper use of these devices and their disposition. This memo was sent to the ATA NDT Panel and Selected E&M Executives since it affected the use and disposition of isotope devices used in radiography inspections. However one ATA member pointed out, and the NRC has confirmed, that adoption of this proposed rule would also impact the use of other radioactive devices such as luminous emergency exit signs, radioactive sensors used in aircraft indication and communication systems, certain counterbalance weights and most likely, aircraft smoke detectors.
The ref. memo requested your comments on this subject to ATA by March 2, 1992. ATA requests that your comments reflect what impact the adoption of this rule would have on your material management of these other devices mentioned in addition to isotopes used for NDT inspection.
D. Lotterer/ATA
J Air Transport Association (ata)
OF AMERICA FOR USE OF lll!MBERS OHL Y 1709 New York Avenue, NW Washington, DC 20006 Phone(202) 626-4000 January 27, 1992 COMMENTS FOR RECEIPT AT ATA BY MARCH 2, 1992 MISCELLANEOUS MEMORANDUM NO. 92-10
SUBJECT:
Requirements for the Possession of Industrial Devices Containing Byproduct Material-NRC Proposed Rule To:
ATA/NDT Panel Selected E&M Executives Attached is a proposed rule which if adopted, would require general licensees who posses the subject devices to provide the NRC information about identification of such devices and about the people responsible responsible for such devices. This information would be reported quarterly.
Please send your comments on this subject to ATA by March 2, 1992.
Attachment David Letterer Director-Airworthiness and Technical Standards
I t
f
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[Doclletilo.~J RIN 0583-AAAS
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ACTION: Pu,'l'oaed 1'm'e'; flfflpening of CO'l'ftineft't J'l',!'riol!.
SUD
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F5IS has lll!lCll!!ffed
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DATI!: Comment!! must hr l"l!IOO.-.ed._.
bef~~U.1al.
M:IDflrDSl!I: Wrfflen mmmentll k:r.
Pohcy Office. 1'.ttn: Unda Ottey. 'PStS Hearin,g Oez\\:,.room 3111.. Smrth A:grlc,rltnre lhlikling. 'Food 'Safefy amt Inspecfitm 'Servtce. U.S. Depa:rt:ment ~r Agricultll'.nl, Wnhmg:tcm.DC.m:m. Oral cam.menu as prnvkh!d by '!be Ptrnttey Pmducts fmlpecth::m h.1 whomd be directed 'to Mr. -..r;Htmn C. 9mftb.. ll"t tml n&--9916.
FOR fUR'RtEIII INf'OIUIATION COlff ACT:
W' Mr. William C. Slllith. Directar.
Proceased ProductJI lnlij)e(:tlon DivlllWn.
Science.and Technology. Food Saietf and Inspection Serv1ce, U.S. Department of Asncul tur.e. W a.sliington. DC 20250.
Area Code I202J 720-3849.
IUPPLEIIBtQ'at' CWT Ail* nGH:
C¥trently.,q\\Uili ty COBiro1 prosr.ama regaroia,g fm.islied,PnMt-..ot.l:ruripedion ol thenmill~ sli,eJf atab1e G&ftMd producte llH:111.t oomply widl &pedfic reqw.remeRl!li of sectlQlla JUl.309-m 381.300.of the Feder.a.I aeet alld pow.Ivy product& ~
~oons. The J\\.gency received two peatmns H'8BI.the National Food Prooeasora Auocia.tion (NFP Aj to.ameJ;1d the Federal m.ea.t and pettltry prgdw::.tli 11'11ip8Ct1'Xl ~" la ti,Qna to allow cwwmg eaa..bhiameais morie iautu.de ia wmply"1g w.ilb.the raquinm.enUI ~la:lned Ul aeclima11 318.309 and 381.309 'ilf' tli.e Feeler.al meat and poultry.prod,uc.t,, Saspeclmn regu1a tion.'I.
o....,....,..... a&. l:illt. ms pubtimla:i
- pt14W.etl fllllle '-II.Fi !Mml) to -11hellcdmane*am:il)lllllsry products* 1* tiw1.....-- iealmw quality control progiams.., tlift'l!r 6'am currelll:Jle....., requirfamlL SM.ca proszw-ant be aeterained.. oe equi.... lalt to ta Cm.'ll!Jllt ~
req~eata CII' meet.., Wetll ei.-ch reqwnma*whioh**pmride l&IIIY'P,ttl, ll;e Nfet)' -.d *l:rtut,f uf canned~
~
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- CIFll--~*-Mdfl RIN.S1so-.ADU
~fur'tl:a'P011nslano'I lhdua'b111 'Dlilllcw Con'bllnlna Byproduct ldw, 11111
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ACTION: Prope9ell t'IM.
....... 1111111'! n.e Nttclear ite,p:latC)'
C;,,._ isNoa (MIC} ii 1'")P'811i11g lo amm.d ib~tkm*-F~ tbe sde use el~
matemai in :certain m~
lll'lllfPQI. or oanb"Dllm8 devices. Tile pl'()JX)9H ~
..:ll:'IIICJll8 other thuwa,...W.J."l!llil.lUf weneral licensees whoJ)ONe11 !beae dew:lel to pMvide. NRC infomtation a.boat d!lll ldentffica-t.ioa of derices em.I tbe ~
responsible for the devl.cea. further.
specific Jicenaees who.a;re dis.lrihutots of g~y li00il::98d dettioes under W CPR n.s IM,')uld be nequired to tt11e a wufoaill mrznat when whmittiq the quart.er!}' tnmuer reports lo NRC. The
~
ral.e ltl iru.ended to ensure that gtmerld.lioenaees are *ware r,f ud unden.t.i.ad tla,e ~
fur ~e pO!lseSMGa af del'ices wnkl.inillg byproduct mat.ariaJ. Thia aw4lll!lllellS 11rill better &allloH"e that~~ will
~f wLta di.e~ Sor,PN)?f'..r handlmg.and di.apGlll,a1 GI. aea,eraliy Ucenad i.ie'lllioes.-i ~ly ffldure the palmilal farir,; t1 11 t6ia! Oliluld rendt m u:arec:eawr radiation~
to the pubii.c:.
DATU: The comment period expires March 12. 1992. Comments retll!n'ed after this.date will be considered if i.t JS prac'ticab~e le do so. but &he 'NRC is able to ensure.consideration o~y fer comments received on or before tb1s dale.
ADPPEIMS" M..n wriUen-00mJaeR.11i.W the Seali!ta:ry. U.S. l\\11teieal-R.e.swla1:Dry Co~ W.-hiqtoa. OC 205iS, A tlentioQ: Deck~ and Sen11,oe 8.r.aacl;,. Ddwer Gilll'lliiDeB1B 4a 011e W.h, !:e Flint Nartk. UW &GNi.:wille Pike.
Rotl¥i:lle. MD. oetweea 7.:.38 am.aoo -115 pm AR ~ya. CoJ,ies af th? p.ni.ft regulimry.wtel,-... well B1I ompiea &l the coma
- tlf,W;let'1ed on die fll"'IIOled rule, may oe-e~ 11t the NRC Publicilecamnt.._, 21>> L Sweet NW. (Lower~ W.ninci;tmi. 0C.
AMI Fa MEIN ~
CCIIR'ACT:
J~,. 'Nwle, Offioe <<'Nucle&r
~.laluryReBe&Tdi. US. Nuclear R~l"J Gwmaisok;.., \\lfashmgffln.
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Bad.glocml O.n F.ehrl.i.a.ry 12. WV,424 FR lQS9J. 1he JUom.i,c ~
Commi111hx1.aiied.its re&'l,llat.f.om.to proride.a~~
for Lbe.use of b~.material co~ in~ bmliowl.. m8aall.l'k1g, ga ~
and~ delt.ices. UruJer tile GW'l',8ll,l.t'eQ lriN!.merl.ta far pgaseni,an of a gener.al lkleme..ce.i1ai.n peraons may receill'e JU:ki wi.e...device.contairung byproduct aa-terial Ji~ devKie has been.mawuaci.u.red.aR.d d.l.a.trlbuted in aocord.u.ce with tlie.,eclicancms contained ht.a.apecifk lia!r.ae iH¥OO by the N&C <<~.wa ~:State. A specific.aceaee,w w.i.ai based UflOll a determination by.a ~tocy ~llJ that t.ae safety.features &f die '1eYloe
.and dte ~
lac sale o_penatio11 are*~,Q-tld moot regttlatt,ry
~nts. Titeperal Ucent1ee is required kJ C61!>,Ply with the.safety iae.tructiol!JI contained iill or referenced oa.tJte W3el of the de-woe end ta :hat-e the tellotimg or e~
of the devrce performed by 111t indivta11ai atrl.Dorized to manufacture. install or servh::e these devices. A generally li-cem!ed devl('e kl *
"biack box..~ that rs.. ibe radimtcbve material ff! aua.tained.in a 11Nled 1'0U1'Ce Ulllla!ly witli:ii.n a sruelded device. Tbe iale1vice is destaned 'W'l'lh mheren t radilltlo!I safety la-aiUN:S 110 tb&t u am be..mt b)' pe,wons w.itil no rarliaU011 trail'IM\\l<<~,cperience. thm.. ~~*
l1cenae ~
ts.a 1J"lecha.r.mm llo
l l
87012 Federal Replter / VoL 56. No. 241 / Friday, December 27, 1991 / Propoled. Rules simplify the lloeme procea so that a have been avoided. In addition. the compatibility. The Commiaalon would caae-by-caae detemtination of the cleanup coatl were in 8'XC8U of four appreciate comments on this suggestion.
adequacy of the radiation training or million dollara with additional coat&
An estimated 35.000 persons use experience of each user ia not incurred for the staff efforta of certain measuring, gauging, or necessary.
regulatory agenc:lo.
controlling devices under the NRC's Discme1on In CODllderation of both the risk general license. NRC regulations that There are about 600,000 devices that asseament and incidente lilc.e those affect these general licensees' noted above. the NRC conducted a resporu1ibllitie1 and that are presently contain byproduct material it use by three-year eampltng (UIM tbrn 1986) of being amended are 10 CFR 31.2, 31.4.
about SS.000 Ucensees under the general licemeea (taken from the 31.S. and 31.6. Under 10 CFR 31.2.
Comminion'* general license regulatory vmdor'1 C' reports) to detennine "Terms and Conditions," all general program. General licensee, have not whether ere waa an accounting licensees are subject to certain been contected by NRC on a regular problem with pup usera under general provision* of part 30 and also parts 19.
basis becat198 of the relatively small licemea, and If ao. what remedial action 20, and zt. The propo..,hevision to
)
radiation risk posed by generally might be neceuary. The sampling was I S1.2 would.alao subject all general licensed devices. These drncea have conducted both by telephone calla and licensee1 to the-requirements of 10 CFR survived fires and explosiOlll on many trite vilita. The sampling revealed 30.9, "Completeness and Accuracy of occasions without a total lou of several areas of concern regarding the Information." which imposes certain sblelding. They have been damaged by UH of radioactive material under the requirements regarding the molten 1teeL and bit by comtmction general license provisions. On the basis completenesa and accuracy of the veblcles with only minor Jones in of the sampling. the NRC concluded that information submitted to the NRC by radiation sblelding while maintaining is: (1) A lack of awareneu of licensees not now imposed upon general the int:ret:! the source capsule.
appropriate regulationa on the part of lic:enseea.
None there have been a the user (general licensee) and (2)
Section 31.4 of 10 CPR part 31, number of occwrences where devices conta.inhl3 radioactiYe material a,1ve not inadequate handlins and accounting for "Information Collection Requirements:
been=ly handled or disposed of these generally licenaed devicea. The 0MB approval," lists the various and ted in radiation exposure of the NRC further concluded that these two section, of part 31 that contain
~
Althou,gh DO lipiflca.nt public
( problema could be n,medied by more approved information collection and safety huarda tMulted from frequent and timely contact between the requirements.Paragraph (b) of§ 31.4 is these incidents,.if proper ~
and general liceriaee and the NRC. Thia - '*
being amended to add I 31.6 to the diaposa1 procedures had been'fo owed, condu.sion by the WC previde1 lbs. :
approved Hating.
these avoidable expo,urea would not basis for the regulatory chanpa Section p.s. "Certain measuring, have occurred. Por example, one or proposed in this action.
gauging or controlling devicea." provides more cesium-type ga~ were mixed in An estimated 7D.800 Agreement State for a aeneral-licensee to acquire.
with IODle scrap me that was melted licenaeea use the types of sources and receive. posse&S, use. or transfer down to form steel and the entire batch devices covered by the amendments byproduct materials. It also specifies the of steel was contaminated. In another being proposed.today for the NRC's responsibilities of-general licensees instance, a atetic eliminator bar with general licenseea. Consequently, the regarding the Wle of byproduct 22.5 nUillcuriea of americium-241 was States will play an imwrtant role in material,. Under the proposed revisions sent to It sanitary landfill over which the achieving improved regulatory oversight a new paragrap9 (c)(ll) would be added NRC has no jumdiction. Th.ere have on a national baaia. Manili of the States to require the general licensee to been other types of incidents involving already have accountab' ty programs in provide specific information to the NRC NRC generally licensed devices place. The Agreement States upon requesl This information would including damaged devices, leaking or participated in the development of this include the complete name and address:
contaminated sources, and equipment rule and indicated agreement with the specific information about the device, malfunctions. Howe\\ler, lose of concept of the proposed rule. Specific such as manufacturer, model number.
accountability, as ocCUJTed above, comments from the Agreement States and.number of devices; name, title, and remains the most frequent incident and were adopted except for ~Hons telephone number of the person the predominant concern.
that the NRC charge gene licensees responsible for controlling the use of the Because of these occurrences, the fee1 and that there ii no need for a device; the address where the device ls NRC's Office of Nuclear Material Safety standard format for aubmittlng located or used; and whether the and Safeguard.a (NMSS) conducted a information. The fee isaue will be specific requirements of paragraph ( c) of radiological risk assessment addressing addressed separately. The proposed rule
§-81,5 have been meL In addition. a storage of devices in warehouses, provides flexibility in the use of the proposed revision to paragraph {b) of disposal in scrap yards, incineration of standard format I 31.6 wouid delete all references to waste, melting in a smelter, and disposal The Commission is considering tpeclfic licenses i88ued by Agreement in a landfill. NMSS included in the risk malting the amendments a matter of tates that authorize distribution of assessment an incident at a steel compatibility for the States. The NRC devices to peMlons generally licensed by company in 1983 (discussed in NUREG-staff has suggested that the amendments Agreement States.
11138. "The Auburn Steel Company be categoriud ae Division 2 level of The registration and verification Radioactive Contamination Incident")
compatibility. Thia level of compatibility system contained in the proposed that probably represents a worBt-case requirea thet Stetes address provisions amendments to 10 CFR parts 31 and 32 scenario for generally licensed 11al18ins in NRC regulationa relating to basic will include all general licensees, devices. Although individual doses were principles of radiation safety and including those who pre".iously acquired low and within preacrlbed limits for regulatory functions without necessarily radioactive eourcea.. If older sources are exposure of memben of the public. they using Identical language. States may transferred. they would be subject to the neverthelett repre1ent unneceaaary also adopt requirements more restrictive IB.IIle requirements as newer 1110urces additional public exposure that could than NRC rules under tbla level of and the registration syatem is intended
~
Federal Register / Vol. 56, No. 249 / Friday, December 27. *1991 / Proposed Rules 67013 to capture them. General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing provisions of 10 CFR 31.5{c)-(8) and (9).
In both cases, licensees must notify the NRC of the transfers. If the specific licensee Is a 10 CFR part 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply to any subsequent transfers. The current NRC data base, although limited. includes identification of general licensees who acquired gauges es early as 1959. The NRC staff plans to contact these licensees and any new general licensee as part of the enhanced oversight effort.
At present. 10 CFR 31.6, "General license to Install devices generally licensed in I 31.5," provides a general license to certain specific licensees from A\\iueement States to install or service
-evices used under I 31.5. The current regulation, 10 CFR 31.A is not clear with respect to time restrictions. 10 CFR 150.20(b)(3), imposes a 18Ckiay-per-celendar-year limitation on the activities of Agreement State Llcenaees In non-Agreement Stat1n. The proposed amendments to I 31.6 would remove this restriction for I 31.5 licensees. This change will be convenient to the NRC.
Agreement States, and manufacturers because It will reduce and simplify paper work without increasing the risk to public health and safety. The proposed I 31.6{a) would require the general licensee holding a specific license from an Agreement State to report to the NRC all persons receiving a device from the licensee, es specified in
-_he accompanying proposed revision to
-L 32.52. Proposed I 31.B{d) would require the licensee to supply each of the recipients of a generally licensed device a copy of the general license contained in§ 31.5. Proposed I 31.6(e) would reqwre that written Instructions and precautions be provided to persons servicing a generally licensed device.
Proposed I 31.6(0 would also require a person performing routine installation/
(
servicing/relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to the start of the activities. This notification would allow for a level of periodic Inspection of those activities that Intentionally piece a worker in direct contact with the de\\1ce or an unshielded radiation source. It is not Intended that the prior notification requirement apply in case11 where a radiological hazard due to an accident or a malfunction of the device exists. To be consistent with the proposed modifications. the section heading would be a.mended to read "General license to distribute, install. and service devices generally licensed in§ 31.5."
10 CFR 32.Sle, Same: Conditions of licenses," presently imposes conditions on applicants for a specific license to manufacture or initially transfer generally licensed devices to general licensees. The addition of proposed paragraph (c) to I 32.51a would require such specific licensees to provide recipient users of generally licensed devices with written instructions and precaution11 to ensure that the devices are used safely. In addition. these specific licensees would be required to provide those users with information regarding testing requirements, transfer end reporting requirements. and disposal options for the devices being transferred 10 CPR 32.52, "Material transfer reports and records," currently requires specific licensees authorized to distribute devices to general licensees to file transfer reports with the NRC on a quarterly basis. The revised regulation would prescribe the format to be used when submitting transfer reports to the NRC. The _proposed format would provide more detailed and complete information about the general licensee to whom the device Is transferred. The format la presented in proposed subpart E, I 32.310. Llcenseea who do not use the prescribed format would be permitted to provide all of the infonnation required by the format on a clear and legible record. In addition. specific licensees would be required to identify a person responsible for meeting the requirements associated with the po88ession of the generally licensed device rather than simply identifying a point of contact at the general licensee's location.
After receipt of the quarterly transfer reports from the specific licensee under i 32.52. the NRC would aend letters to the general licensees who received the devices during the preceding reporting period requesting them to verify In writing that they had pqrchased the devices containing byproduct material end that they understand the requirements of the general license. The general licensee under proposed I 31.5(c)(11)(1i) would be required to respond to the NRC by letter and to verify safety-related information about the device and its location. Thereafter, notices would be sent periodically to the general licensees requesting that they verify that they still have the device, verify the safety-related Information.
end remind them of their regulatory responsibilities In using the device. The frequency of these letters may range from 1 to 3 years. Any failure to respond or any reports of lost devices would lnltlate NRC follow-up action. This contact between the NRC and the general licensee would allow the NRC to validate and update the information currently contained in the data base that the NRC maintains for its general licensees.
Although these proposed requirements would impose additional costs on licensees, the Commission has estimated these to be nominal (on the order of $10 per device). Accordingly.
the Commission believes that the Increased compliance by general licensees and confidence in the appropriateness of the general license program potentially afforded by these new requirements outweigh this cost.
Nonetheless, the Commission particularly requests commen*ts on this matter.
At the time of the final rulemaking on this matter, the Commission Intends to provide for en interim enforcement policy to supplement the current Enforcement Policy In 10 CFR part 2.
appendix C. to address violations arising from the proposed regulations.
The interim policy would remain in effect for one cycle of the notice and response program. approximately three years. Under the existing NRC Enforcement Policy, significant violations such as those Involving lost sources may result In escalated action including civil penalties. The interim policy would provide that In the Initial phase of the implementation of a notice and response program, enforcement action would not normally be taken for violations identified by a licensee In submitting Information pursuant to the proposed regulation provided appropriate corrective action is Initiated This change from the Commission's normal enforcement policy In 10 CFR part 2, appendix C, is to remove any disincentive to Identify deficiencies caused by a concern of potential enforcement action. This action would be taken to encourage general licensees to search their facilities to assure sources are located, to determine If applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found However, enforcement action will be considered for violations involving the failure to provide the lnformabon requested or take appropriate corrective actions or willful violations including the submittal of false information. Sanctions In those situations may include civil penalties ea well ea orders to limit or revoke the
Fedmal Ra11lw,r / Vol 5ft. No. 249- / Friday, December 27. 1991 / Proposed Rules authority to puueaa ndioectiwe aources under a g,meral. license.
Enviromnantal Impact: Categmh:al Excluaion The NRC ha.a det.arminad the.t the proposed regulstiolla are tlie type of action described in the categorical exclusion 10 CFR 51.Z2(cJ[3)(iil).
Therefore, neither en environmental impact atatement nor an environmental assessment hes been prepared for this propoaed regulation.
Paperwork R,w;luctkm -'ct Statement The proposed nae ameodii the information collection requiremeai:s that are subject to tae Plipenmd: Reduction Act of 1980 (44 U.S.C. 3501. et aeq.). Tids propoeed role haa bean nbmitted to the Offk.e of Managammt ami Sadget for review and aJIJIJOYm of the paperw<<:n requirements.
The public reporting burden for lbw collection of iifomuulan 11 estimated to average about zo minute>> per reaponee, includuig time fut re\\de.wing instructloR.S, aea.rchmg existing data sourcea. g.athemis and maintaining the date needed. and completing. aad reviewing the collection of i.uformation Send cammen.ta regarding \\his bw-de11 estimate or any otaer aspect of this collection of information. including suggestions £or reducing th.la burden. to the Information and Records Management Branch (Mr-,."B&--7714), U.S.
Nuclear Regulatory Commission.
Washington, DC 20555, end to the Desk OffJ.Ctt, Office of Information a:1d Regulatory Affairs, NEOB-3ol9, (3150-0016 end 3150--0001), Office of Management and Budget. Washington.
DC.Z0503.
Regulatory Analysis Tl:e NRC has prepared a draft regulatory analysis of this proposed regulation. The analyais examines the cost and benefits of the altemetins considered by the NRC. The draft analyslB is available for inspection in the NRC Public Document Room, Zl.20 L Street NW. (Lower Level}. Wuhiil@ton.
DC. Smgle copies of the draft ana}yais may te obtained from Joaeph J. Mate, Officer of Nuclear Regulatory Research, U.S. Nt>Clear Regulatory f'.nmm1eSJon.
Washington. DC 20555. telephone: 301-492-3795.
Regulatory F1exi"bUity Certification Based on information available at this stage of the rulin11aldng proceedmg and in accordance with the Reswatory Flexibilrty Act. 6 U.S.C. 606{b}. the NRC certifies that. if promulsa\\ed. this rule will not have a aisnificant ecoaamic imp a ct on a sub, tanti&l number of amall entities. Tne NRC ha& a:dopted ai:ie standartH &ie.t claaaify II small entity as one whe-, grees annual receipts do not exceed $3.5 milll9n over a 3-year period The proposed rule affects alxn.11 35,,Wl perB0118 usmg products wnder tll1s general liceme, many Qf whom would be classified aa a,man entity. However.
the NRC helievea that the econon;.ic impacl uf tu proposed requil'eJllellt>> Im any general licensee would be negligible. The proposed rule is being
~sued to betler enaw-e tbat the general licenaeea UDderstand and comply with regulatory te11ponsibilitie1 regarding the generally licensed radioactive devices In their pcreHlon.
Backfit Analym The NRG has determined that the backfit rule, 10 CFR 50.109, does not apply to tlie:.e proposed rules and thare£ore a hackfit analyllis la not required bee.a.use these proposed ameruhnpnts do. J10t involve any profflolilHa that would impose bacldits as defined in 10 CFR 50.lOO{a)(1).
ListefSul,fectshr.
10 CFR Part 3.1 Byprodect material, Criminal penaltiea, Labeling. Nuclear materials.
Pac:ka~ and cootainen, Radiation protiectim. R~
BIHi recordkeeping requirements, and Scientific equipment 10 CFR Part 32 Bypmdm:t material. Cnminal penalties. Labeling, Nuclear materials, Radhttion protection, Reporting and recordkeeping requirements, and Scientific equipment.
For the rea90D8 set ont in the preamble and mider the authority of the Atomic Bnergy Act of 1954, as amended.
the Energy Reorganization Act of 1W4, as amended. and 5 U.S.C. 553, the NRC is propt>SfBg to adopt the following amendnteHts to 10 CYR parts 31 and 32.
PART 31-GENERAL DOM£STlC LICENSES FOR BYPRODUCT MATERIAL
- 1. The authonty cite lion for part 31 is revised to read as follows:
Authority: Secs. 8L 161, 183, 68 Stal 935, 948, 9M. aa amended (42 IJ.S.C. Z111. 2201.
2233); seca. 201, 11& 11mend11d, :t02.. 88 Stal 1242. as amenc.e.i. 12.44 (42 U.S.C. 5841. 5&42).
SeclJoo 31 S also 1asucd under sec. 274. 7J St11L MB (42 U.S.C. 2021)
For the pm-poses of sec 223, 68 Stal 958, as amended (42 U.S.C. 2273}: H 31.5 (c)(1H3) and (5H9). SUI, :tl.8{c}. 31 tO[b). and :n ll[b).
[c), and (d) are iuued under tee 161b, 118 Stat 948. u amended (42 U.S C. %201[b}: and U 3U (c){4). (~}. (BJ. IIIld [11). 31.6 (dHf),
and 31.U(b) lllld {a) are lHUtJd under ec. 1610. SB Stat. 950. as amended (42 U.S.C 2201(0)).
- 2. Section 31.2 is revised to read as follows:
§ 31.2 "Fenna and Condition&.
The general licenae1 provided in thm part are subjact to the proYi ion of U 30.9. 30.14{d), :na.t(a) to (e), 30.41, 30.51 to 3Q.63, and parts 19, 2.0, end 21 of this chapter 1 unless indicated otherwise In the language of the general license.
- 3. In I 31.4 paragraph (b J ts revised to read a follows:
f 31.4 Information conectlon requirements: 0118 approval.
(b) The appro,*ed informa!ign collection requiremenlB contained m this part appear in U 31.5. 31.6. 31.8. and 31.11.
- 4. In I 31.S. paragraph (b),s reV1sed and paragraph (c)(11) Is added to read as follows:
§ 11.5 Certain meuurtng, gauging, or controllfng devlcft. I (b) The general license in paragraph (a) of thi11 section applies only to byproduct material contained in de\\ices that have been manufactured or initially transferred and labeled in accordance with the 11pecifications contained in a specific llce.D8e Issued pursuant to
§ 32.51 of this chapter or in accordance with the specifications contained in the general licenBe of § 31.6.
(c) * * *
(11) Shall respond withID 30 calendar days of receipt of a request from the Nuclear Regulatory Commission to verify the following information and any other auch information as may be requested by the Commlasion as it relates to the general license. Further.
the general licensee ahall notify the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory CoJllBl.i.ssion, Washington DC 20555 w1thm 30 calendar days if any of the requested information should change.
(1) Name and complete address of the general licensee.
(ii) Identincabon of specific information about the device. such as*
the manufacturer, model number. the
- Alll!fl'ltln ts d,r,,,:ti,d par11culariy lo the prmmona oi tbe ~t10IU1 tn part 20 of th.,,
chapter that relate to the labehng of cootamers
- P,,raana iw-Ull! bvproduct malarial tn dev1ce1 under a general hcenae in § 31..'i before Janwuy 15. 19'15. ma:, contmut! to p091tn. ine or tra11afer that mawnl III accordance,..,th Iha labeling req~ of I 31.5 ID eff1tel on }anumr, 14 19'75
Federal Reglater / Vol. 56, No. 249 / Friday, December 27, 1991 / Proposed Rules 67015 number of devices, type of Isotope, and (Regional Office listed in Appendix D of who has performed what service on the part 20 of this chapter at least 3 working device since the last report concerning day prior to engaging in auch activities the device wa11 submitted to the NRC.
- 1n Non-Agreement Statea. The (iii) Name, title, and telephone number notification shall include the date and of the person who is responsible for the location of the activity that will be device and for ensuring compliance with performed. Prior notification doea not the appropriate regulations and apply In cases where a radiological requlrementa.
hazard due to an accident or (Iv) Address at which the device Is ma1function of the device exists.
located or used.
(v) Whether the requirementa of
§ 31.5(c)(l) through (c)(lO) have been met.
- 5. Section 31.6 is amended by revising the section headjng and the introductory paragraph and by adding paragraphs (a),
(d), (e), and (f) to read as follows:
§ 31.1 General lloeflN to dlstrtbuta, !natal, and WYlc9 de¥lcee genwaly lcenNd In 111.5.
Any penon who holds e specific license by an Agreement State authorizing the holder to manufacture, distribute. install, or service devices described in I 31.5 within the Agreement State ia hereby granted a general llceme to distribute, install or service the devicea in any non-Agreement State for an unlimited period of time and a general license to diatribute, install, or service the devices in offshore waters, a defined In
§ 150.3(f), provided that (a) The Agreement State licensee files the appropriate transfer reports as required by paragraphs (a) and (b) of I 32.52.
(d) The peraon shall furnish a copy of the general license contained In § 31.5 of this chapter to each person who is responsible for the byproduct material and for ensuring compliance with the appropriate regulatioilf! and requirements.
(e) The peraon shall provide the individual responsible for service of the device with written IIlStructiona and precautions necessary to ensure its safe installation. operation, and service.
These instructions shall include leak-testing requirementa, transfer and reporting requirements, disposal options, including possible costs and reporting requirements for lost or damaged devices.
(
(f) The person performing routine serv1ce/installalion or relocation of device~ shall notify the appropriate NRC PART a2-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 6. The authority citation for part 32 continues to read as follows:
Autbortty: Secs. 81, 181. 18Z. 183, 68 Stal 935, 948, 953. 954, H amended ( 42 U.s.c. Z111, 2201, 2232. 2233); NC. 201, 68 Stal 1242. a amended ("2 u.s.c. 68'1).
For the purpoees of sec. 223. 88 Stal 958. u amended (42 U.S.C. 2273); II 32.13, 32.15 (a),
(c), and (d), 32.19, 32.25 (a) and (b), 32.29 (a) and (b), 32.M. 32.55 (a), (bl, and (d), 32.58.
32.59, 32.62. and 32.210 are 1aued under aec.
161b, 68 Stal IM8. a amended (42 U.S.C. 2201 (b It, and II 32. 12, 32. 16, 32.20. 32.25( c ),
32.29{ c), 32.51a, 32.52. 32.56, md 32.210 are inued under aec. 1610, 68 Stal 9SO. as amended (42 U.S.C. Z201(o)).
- 7. Section 32.51a is amended by adding paragraph (c) to read aa follows:
(c) Furnish the individuals Identified under§ 31.s{c)(ll} or I 31.6(d) with written instructions and precautions necessary to ensure safe installation.
operation. and service of the device.
These instructions must include the leak-testing requirements, transfer and reporting requirements, disposal options including po881ble costs, and reporting requirementa for lost or damaged devices.
- 8. Section 32.52 !a revised to read as follows:
§ 32.52 Same: Matert&I tranaf<< reports and records.
Each person licenaed under § 32.61 or
§ 31.6 to initially transfer devices to generally licensed persons shall:
(a) Report quarterly to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission. Washington. DC 20555, and send a copy of the report to the appropriate NRC regional office listed in appendix D of part 20 of this chapter all transfers of such devices to persons for use under the general license In § 31.5 of this chapter. The report must be provided either in the format presented in aubpart E, § 32.310. Transfer Report Format," or on a clear and legible record as long as all of the data required by the format is included. If one or more intermediate persons temporarily posaesaes the device at the Intended place of UM! prior to ita poHesslon by the UBeT, the report must include the same information for each intermediary as in subpart E. § 32.310, and clearly designate that person as an intermediary. If no transfers have been made to persona generally llcensed under I 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of-the end of the calendar quarter.
(b) Report quarterly to the responsible Agreement State agency all transfers of such devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.5.
The report must be provided either In the format In subpart E. I 32.310,
Transfer Report Format," or on a clear and legible record as long as all of the data required by the format is included.
If one or more intermediate persons temporarily possesses the device at the Intended place of UBe prior to Its posseHion by the user, the report must include the same information for each intermediary as in subpart E. § 32.310, and clearly designate that person as an intermediary. If no transfers have been made to peraons generally licensed under § 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.
(c) Keep records of all transfers of such devices for each general licensee and In compliance with the above reporting requirements of § 32.52.
Records required by this seclion must be maintained for a period of 5 years from the date of the recorded event.
- 9. Subpart E. § 32.310 is added to 10 CFR part 32 to read as follows:
Subpart E-Report of Transfer of Byproduct Matertala
§ 32.310 Transfer Report Format.
This section contains the format required by § 32.52.
IIIUJNO CODE _,-1,1
61016 Fedaral Reptar / Vu. 5B, Ne. :149- / Friday, December 27, 1991 / Propoeed Rnles Subpart E-Report of Transfer of Byproduct MatertaJs Section 32.310 - Transfer Report Format NAME OF VENDOR AND LICENSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE lNFORMATION COMPANY NAME, STREET, CITY,,
DEPARTMENT STATE, ZIP CODE 0 ERSON RESPONSIBLE FOR CONTROL OF THE DEVICE NAME AND TITLE.
TELEPHONE NUMBER FOR EACH DEV1CE PROVroe THE FOLLOWING t.AODEL SERlAL ISOTOPE ACTIVITY ANO UNfTS NUMBER NUMBER l
I IIIUJMO COOi 7H0-01-C
C Fedana P afrt** / Vol. 18. No. Ml/ Friday, December r,, 1991 / Propoeed ltldea
Subject:
Reqairaaeuta far die Poueaian of IDdmlrial.lleftms Containing Byprodact M t rial (RIN 8150-ADM).
Dated.. R1d"rille, ~1hiafflh day of December 11181..
F<< 1tte Nttdear ~latoryCumnd111on.
Jama M. Tayb, Execuli~ Dirsctor for Operatians.
[FR Doc. ln-311829 Filed 1l-2&-91; a:-&5 amJ N.UNGCODE~
DEPARTIIENT OF TRANSPORTATION Federal blatlon Admlnlstrdon 14CFRParU9
[Docket No. lM:E-n-.ADJ
~OncU
~
DHC-3 Otter Aa MDCY: Federal Aviation Administration. DOT.
AC110N: Notice of propoeed rulemaking (NPRM).
-MAlff: This notice propotN to adopt a new airwortbines1 directive (AD) that would be applicable.., deHaYilland Model DHC-3 Otter airp1anel that ltave a Servo-Aero Engineering Z6000 Serles Kit inatalled on a Pratt A Whitney PT6A-U5/135A engine. Thla proposed action woo.ld require a one-time inspection to ensure existence and correct Hsembly ~ the fuel condition lever ioclc. and. if not exiatent or incorrectly auembled. installation in accordance with the applicable &erYice anformation. If the fuel condition lever 9ock Is not eXIatent or incorrectly asoembled, inadvertent engine shutdown could occur. The actions specified in thi.a propoaed AD are intended to prevent 1011.11 of control of the all'J)lane caused by inadvertent engine 11hutdown.
DATU: Comments must be received on or before February 3. 1992.
ADORUSD: Servo-Aero F.nglneering Service Bulletin S8001, dated July 24, 1990, may be obtained form Servo-Aero Engmeering Inc., 37 Mortensen Avenue, Salma11, Cahfomia 93905; Telephone
(-100 422-7800}. Thi11 trJormation also may be eJtamlned at the Rules Docket at the addreaa below. Send col'IUl1ent9 on the propoaal in triphcate to the Federal Aviation Ad.JniIMtration (FAA). Central Region, Office of the Assistant Chief Counael, Attention: Rules Docut No.
91-CE-78-AD, room 1558. 801 E. 1Zth Street. Kanau City, MislO'Dri 6'106.
Comment. may be inspected at this locat!tm between 8 Lm. and 4 p.m~
Monday...... Priay, holidays excepted.
FOIi fUll'JI-NIQllafflCttCOIR'ACT:
Mr. CWnb v-.. Aentapeca ec:r::*
FAA. Loa Aawel-Aircraft tiou Office, S129 E. Spring 8mm Long Beach. CaHfomia 98806-2425; T-elepbone (21~) 1188-SZM; Facsimlle (%13) 1118-&1.0.
8UPl'\\WMY NOIIIU.110N:.
Comrnbhawted Intereetad penom are invited to participate In the ~
of tAe proposed rule by 111bmitting 1uch written data. views, Of' BllJJUNJQta U they may desire. Commtmicationa should Identify the regulatory docket number and be Rbmitted in triplicate to the address apeci6ect above. All r.nmm1mlcatioaa reoeived oa or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The propoeala *.,....t,wi in this aotiae may be changed in light of the comments received.
Comments are specifically invited on the overall regulatory, economic, environmental and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, 1n the Rules Docket for examination by Interested persona. A report that summarizes each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.
Availabillty of NPRMs Any person may obtain a copy of this NPRM by submitting a request to the FAA. Central Region. Office of the Auiatant Chief CINllsel. Attention:
Rl,llea Docket No. 91-CE--73-AD, room 1558, 801 E. 12th Street. Kansas City, Miuouri &1106.
l'llK11t1Rioo Tramiport Canada, which is the ainrorthinen authority for Can11da, recently notified the FAA that llD u.nsafe condition may exist on certain deHavilland Model DHC-3 Otter airplane11 that have a Servo-Aero Engineering 20000 Serie9 Kit installed on a Pratt A: Whitney PT6A-135/135A engine. Transport Canada 11dvires that some of the Pratt A: Whitney Canada PT6A-135/135A engines that have been modified 1n llCCOrdance with either Supplemental Type Approval (STA) SA 89-32 or Supplemental Type Certificate (STC) SA 3777NM do not have a fuel condition lever lock installed. H the fuel condition lever lode is not imtailed or iti inCO?NICtly assembled. then the engine can inadwenendy uwtdown and retJUlt 1n.loee of controi of the eu,nne.
Seno-Aero Buglneeri~ Inc. 1la11 is111ed Serria! Bulletin 88001, da~ July 24, 1991, whkh epedfiet mstructkms for install~ the fuel condition level lode.
part nmab8!' {P(Nl 2003'1-UJ. Tnm9port C8llada daaeified t1ria eemce bulletin as mendatory and inued Transport Canada AD DV-912-16, dated fune 11, 1991, 1n order to assure the airwortluneu of theN airplanea in Canada. The airplanes are mm,afact~ tn Canada and are type certificated for operation in the United States. Pursuant lo* bilateral airworthlneu agreement, TrallBport Canada has kept the FAA totally Informed of the above situation.'~
The FAA hu examined the findings of Tnmaport Canada. reviewed all available information. and determined that AD action ia D9Ctl988f)' for ~s of this type design that are certificated for operation In the United States. Since thia ooodttioo could exist or dMek,p in other deHavilland Model DHC-3 Otter ahp1aaea that have a ServcrAMO Engineering 200IIO Seriea.kit installed on a Pratt & Whitney PT6A-135/135A engine of the same type design. the propoeed AD would require a one-time ln11pectlon to ensure e,cistence and correct uaembly of the fuel condition lever lock. and, if not exiatent or 1 incon-ectly aHembled, installation In accordance with the instructinm in Servo-Aero Service Bunetln SBOOl, dated July 24. 1991.
It ia estimated that 2 airplanes in the U.S. regutry would be affected by the propoaed AD. that it would take approximately 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> per airplane to accomplish the proposed action, and that the average labor rate is approximately $55 an hour. Parts are provided by the manufacturer at no cost.
Baud on these figurea. the total cost Impact of the proposed AD wt U.S.
operators Is estimated to be $t40.
The regulatiom proposed herein would not hava substantial direct effects on the States. on the relatlonahip between the national government and the States. or on the distribution of power and responsibilities among the varlo\\15 level of government Therefore.
In aa:ordance with Executive Order 12612. It is determined that this proposal would not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
For the reasons diiOJ sed above. I certify that thii action (1) Is not a "maJor rule" under Executive Order 12291; (21 is not a "significant rule" under DOT Regw.atory Pol:icie and Procedure ( 44 FR 11084). Febntar, :M. 1979}; e.nd {3) If
The Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Att: Docke ting and Service Branch Re: Proposed Rulemaking: Federal Register Vol. 56 No 249, Page 67011 Dea r Sir/Madam:
This proposal is of significant concern to members of t he International Self-Luminous Manufacturers Association (ISMA),
whom I represent. I understand that copies of the proposal were provided to all general licensees, but not provided to manufacturers. I personally received a copy only last week.
As a result, members of ISMA have not had sufficient time to review the proposal and individually respond.
On behalf of members of ISMA, I request an extension to the commen t period of 60 days, or to May 12, 1992. Please let me know your decision as soon as possibl e.
Sincerely, Vfut William Hj ty President, ISMA Route 2 Box 19C VFW Road, Grasonville, MD 21638 Tel: (301) 827-6022 Fax: (301) 827-9657
U.S. NUCLEAR nEGULATORY COMMISSIOf'.
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Document Statistics Postmark Date 3
I I C o pies Received ___
/ ____ _
Add'I Coptes Rbproduced _;_3 __
Special Distribution D 7? R J:' D.s rn~-re
SHIELD SOURCE INCORPORATED The Secretary U.S. Nuclear Regulatory Commission Washington, DC 30555 Att: Docketing and Service Branch Re: Proposed Rulemaking: 10CFR Parts 31 and 32:
Federal Register Vol 26 No 249 Page 67011:
Requirements for the Possession of Industrial Devices Containing Byeproduct Material.
Gentlemen:
- 92 MAR 16 A10 :l 9 (jJ)
This comment is submitted on behalf of the International Association of Self-Luminous Manufacturers (ISMA). The membership includes all manufacturers of Gaseous Tritium Light Sources (GTLS) in North America and overseas.
Ne ative Im acts Compliance with the proposed changes will increase the amount of paperwork and administrative time required by both general licensees and regulatory agencies. The NRC and Agreement States propose to contact all general licensees directly, to verify information contained in quarterly reports submitted by specific licensees, and to ensure that copies of regulations supplied have been read and understood. Essentially, this duplicates procedures already in place. Furthermore, it has been proposed by Agreement States that the NRC should charge fees to general licensees to cover the costs of these additional procedures. Recent experience has proven that such fees will cause users to cease using radioluminous products, and switch to non-regulated alternates.
In its proposal, the NRC confirms that after investigating all incidents of misuse or improper disposal of generally licensed products, "no significant public health and safety hazards resulted from these incidents.. ". Some small radiation exposures occurred, but even in the worst case scenario.. "individual doses were low and within prescribed limits for exposure of members of the public.. "
We note that in these examples of public radiation exposure, gaseous tritium sources and devices (GTLS) are not mentioned. In our view, the risk to the general public from GTLS under normal and severe conditions of use is far less than that of the products mentioned in the examples, which as stated, have never exposed the public to more than a small fraction of prescribed limits.
Route 2 Box 19C VFW Road, Grasonville, MD 21638 APR 15 1992 Tel: (301 ) 827-6022 Fax: (301 ) 827-9657 Acknowledged bye--' -- ---
trlU """"'"""""' mnm
\\, ~iEGULATORY COMMISSIOt-.
DC:i:;Kl:TING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _3_,_..:.,..f_l ____ _
Copies Received ___
/\\dd'I Copies Reproduced -=-- - ----
Special Distribution S
Y)\\ct.1
The Secretary, USNRC Comments on Proposed Rulemaking Page 2 March 11, 1992 GTLS products have been distributed worldwide to commercial and industrial general licensees since the early sixties. In the United States, GTLS industrial and aircraft emergency exit signs have been sold in production quantities for twenty five years or more. The total devices used, including those now disposed of, is estimated in the millions. Yet we know of no single instance in which a member of the public has ever been exposed to radiation from these devices which could possibly be considered hazardous to health.
These factors suggest that the potential cost and market impact of these proposals are not justified based on the anticipated safety benefits. In particular, the risk to the public from self-luminous emergency exit signs is far outweighed by the known benefit to life safety in building fires that is provided by these reliable products.
By the NRC's own estimate, the cost of instituting the proposals will cost six million dollars, affecting 35,000 general licensees.
No cost impact to specific licensees is given, although increased costs will certainly occur.
Since the general licensee cost impact is based on $10 per device, those using larger quantities of devices will be disproportionately affected. Significantly higher costs will apply to users of self-luminous exit signs than, for example, users of beta gauges or other instruments which have higher unit value and are purchased in much smaller quantities per location.
The NRC's estimate of cost impact of $10 per device is underestimated. A typical licensee will spend a great deal more than $10 per device to complete all research and paperwork required, verify installation locations, verify receipts, confirm understanding of safety instructions, provide product and contact information, and then respond in writing. In any event, the administrative costs are only a part of the total impact on users, which must include the intangible factor of resistance to perceived unecessary paperwork, and non-productive time.
Recent experience of actual cases arising from increased regulatory requirements by some states, and/or fees charged to general licensees, has proven beyond doubt that users of self-luminous exit signs will regard additional regulatory procedures as too costly to justify continued use of the products. They have replaced GTLS devices with electrical devices, which use more energy, cost more to operate, do not offer the reliability of GTLS, but require no such administrative cost. We already know of a number of cases in which the licensee has simply cancelled orders and discontinued use
The Secretary, USNRC Comments on Proposed Rulemaking Page 3 March 11, 1992 of GTLS products, rather than comply with regulatory procedures which are perceived as burdensome.
The proposal to introduce fees to general licensee will increase negative reactions by users of GTLS exit signs. Some states have already introduced fees, which has and will continue to cause loss of business for our members. Even if increased paperwork and administrative costs are accepted, we have found that licensees will reject the payment of any fees for an emergency lighting device and will replace the product with competing electrical signs.
If implemented as proposed, we believe the net economic effect of these proposals could be extremely severe for the GTLS industry, in which emergency exit signs contribute a large fraction of total revenues. The total potential cost impact is estimated at more than
$20 million per year in lost revenues, with associated substantial loss of employment. Such a loss could easily result in the demise of the industry itself.
Finally, the cost to taxpayers cannot be ignored. The NRC proposes to contact in writing and/or by telephone all 35,000 past and present general licensees, for verifications of receipt, transfers, safety instructions, understanding of the regulations, responsible persons, product locations, etc. In our view, this process will result in large government costs out of proportion to the small safety benefits that may result.
Proposals for Revisions to Part 31 The inclusion of gaseous tritium luminous devices in section 31.5 as part of "Certain Measuring, Gauging or Controlling Devices" has implied to specific and general licensees that a similar level of risk applies to all products covered in the section, and that similar regulatory control procedures are justified. We do not agree with this view. There are fundamental differences between GTLS luminous products, and "Measuring, Gauging or Controlling Devices", which difference is in fact implied by the title of the section. They include potential radiation risk, cost per device, typical quantity per site location, and others. A large portion of the section concerning testing for radiation leakage is not applicable to GTLS devices. General licensees are often confused by the overall complexity of the present section 31.5.
In order to help general licensees more clearly understand their obligations specified in 31.5, we propose that specific licensees include a "plain language" interpretation of the regulations in
The Secretary, USNRC Page 4 March 11, 1992 Comments on Proposed Rulemaking each device package. This would be accompanied, as presently required, by a copy of the general license and a statement of the associated Agreement State regulations.
For the past nearly thirty years, GTLS manufacturers have been distributing self-luminous safety devices for use in aircraft containing tritium gas, under specific licenses issued per Section 31.53, to general licensees under section 31.7. Tritium light sources for aircraft signs are manufactured from identical materials as those in commercial exit signs.
We propose that luminous exi t signs for buildings be separated from section 31.5 and either included in section 31.7 of the regulations, together with luminous signs for aircraft, or covered in a new section, 31.8. The building signs would continue to be manufactured under a specific license issued under section 31.51.
The reporting, labelling and propotype testing reuirements would therefore be unchanged from the existing regulations.
Summary of Comments
- 1.
The proposed changes will cause burdensome extra paperwork and administrative costs for manufacturers, general licensees and regulatory agencies.
- 2.
The potential total cost impact and negative market impact are not justified compared to the anticipated safety benefits.
- 3.
The total cost and customer resistance impacts of full implementation of these proposals to the GTLS industry is estimated at more than $20 million per year in lost revenues, with a concurrent risk of liquidation of the entire industry.
- 4.
A large portion of section 31.5 concerning testing for radiation leakage is not applicable to GTLS devices. General licensees are often confused by the complexity of section 31.5, and do not understand the important paragraphs.
- 5.
Radiation r i sk to the public from generally licensed devices has been stated by NRC to be very low. No member of the public has ever been exposed to more than a small fraction of prescribed limits. Risk from gaseous tritium products is even lower than the examples cited, and is outweighed by the known benefits of safety to life offered by these products.
The Secretary, USNRC Comments on Proposed Rulemaking Page 5 March 11, 1992
- 6.
Users of self-luminous exit signs will regard additional regulatory procedures as too costly to justify continued use of the products. They will replace GTLS with electrical signs, which use more energy, cost more to operate and do not offer the reliability of GTLS, but require no such administrative cost.
Proposals A.
Luminous exit signs for buildings to be separated from section 31.5 and either included in section 31.7 of the regula tions, together with luminous signs for aircraft, or covered in a new section, 31.8.
A new title for 31.7 is proposed as:
"Luminous safety devices for use in aircraft and commercial buildings".
B.
With the exception of the proposal above, section 31.5 is adequate and should not be changed.
C.
Present requirements of 31.51 for manufacture and distribution of GTLS safety signs are adequate and should not be changed.
D.
The present reporting requirements for GTLS safety signs under 31.51(a) are adequate and should not be changed.
E.
Each specific licensee should include a "plain language" interpretation of the regulations in each device package distributed to general licensees. This would be in addition to a copy of the general license and a statement of the associated Agreement State regulations.
F.
Fees should not be charged by NRC or Agreement States to general licensees for the use of GTLS safety signs in commercial buildings.
Very truly yours, WiWJ!:t::!:ty President~g;~~A cc: ISMA Members Jay Silberg Esq: Shaw, Pittman
DOCKET NUMBER PR 3 I 3 '-
PROPOSED RUL\\ :;r:, FR' 1,0 Texas Department of He~t~AR 16 m1 :47 David R. Smith, M.D.
Commissioner March 10, 1992 Secretary 1100 West 49th Street Austin, Texas 78756-3189 (512) 458-7111 Radiation Control (512) 834-6688 U.S. Nuclear Regulatory Commission Washington, D.c.
20555 Attn:
Docketing and Service Branch
Dear Sirs:
Robert A. MacLean, M.D.
vi-t. !C!:. QF s~c:,Eep~.'~ Commissioner
- )oCK..-11Nli _.. )Ll<V ICf l
L BR. NCH.
RE:
RIN 3150-AD34 Staff members of the Bureau of Radiation Control have reviewed the proposed rule entitled, "Requirements for the Possession of Industrial Devices Containing Byproduct Material," and offer the following suggestions for consideration.
In addition to the information requested in Section 32.310, we suggest that the Sealed Source and Device Registry number for the device be included on the Transfer Report Format.
To better facil i tate tracking of generally licensed devices, the manufacturer/ distributor should be required to report devices that have been returned to them by the general licensee for disposal.
We appreciate the opportunity to comment on the proposed rule.
If you have any questions, please contact me *
. A David K. Lacker, Chief Bureau of Radiation Control APR 15 1992 '
Acknowledged by card...............................,;;-
U.S. NliUt:AH REGULA TORY COMMISSIOt'-t DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE C01'.*M SSlON Document Stat; tics Postmark Date _3-+-_/_A-____ _
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PROPOSED AUL..:...:.:~...:-1-,,,.... !!)t 1 fJ I
. U~lf 67016
~ederal Register/ Vol. 56, No. 249 / Friday. December 27, 1991 f Proposed Rules
'92 t\\l\\R 16 ~r, '.49 Subpart E-Report of Transfer of By prod~ 1,1;. or-~~
Materials uoc~[1 1NG ~
6Rt-Section 32.310 - Transfer _Report Format NAME OF VENDOR AND LICENSE NUMBER REPORTING PERIOD SRB TECHNOLOGIES, INC.
034-05~4-2'..,
FROM TO
-~
- _2 3/ct/'I 1-.
. ~
~
- 1 GENERAL LICENSEE INFORMATION COMPANY NAME. STREET. CITY.
DEPARTMENT STATE, ZIP CODE RGB GROUP, LTD., PO -BOX 135, Brookfield, CT 06804 na bERSON RESPONSIBLE FOR CONTROL OF THE DEVICE office manager NAME ANO TITLE TELEPHONE NUMBER
'Ann L.* *Morits, office manager (203) 775-0i90
- . FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY ANO UNITS NUMBER NUMBER Quantity of Radioactivit~
/)':>-~~ '-15 (Curies)_
8.9300000 Betalux-E 1o*' year Radionuclide Source H3 WE HAVE FOU EXIT SIGNS.
TH! ABOVE SERIAL 1 ~UMBER IS FOR THE ONE SIGN NOT IN USE.
THE OTHER THREE~ IGNS HAVE BEEN MOUNTED AND, THEREFORE, THE SERIAL UMBER IS NOT EASII Y ACCESSIBLE.
I F YOU NEED FURTHER INFORJ T ION, PLEASE CONT CT THE UNDERSIGNEI.
IF WE KNEW THIS TYPE OF HANijlNG WERE REQUil YOU CAN BE' WE WOULD NEVER VE HAD THEM IN:
ED FOR THESE EXI/ SIGNS TALLED.
p 1< "J:.'hS
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COCKEi~ D ASEA BROWN BOVERI USHHC
[NRC3692]
March 9, 1992 The Secretary U.S. Nuclear Regulatory Commission Washington, o.c.
20555 Attn:
Docketing and Service Branch
Subject:
Comments on RIN 3150-AD34
Dear Sirs:
- 92 HAR 16 A11 :11 one item is unrealistic in the proposed rule, RIN3150-AD34, 10 CFR Parts 31 and 32, Requirements for the Possession of Industrial Devices Containing Byproduct Material.
The proposed Jl.6(f) would require a specific licensee to notify the appropriate NRC regional office at least three days prior to performing routine installation, servicing, or relocation of a device which is approved for distribution to a general licensee.
Such a requirement would impose extremely serious operational and financial burdens on both the specific licensee providing the service and the general licensee receiving the service.
Please consider the following points:
- 1. Industrial gauging devices are used extensively as an integral part of process measurement and control systems such that the manufacturing process cannot be operated satisfactorily without the devices. Examples include papermaking, metals
- rolling, plastics extrusion, rubber calendaring, cigarette making, and other high throughput continuous processes.
These process may run 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> per day, seven days a week.
Any downtime is usually very expensive and must be corrected as quickly as practical. We have over 400 radiologically trained service engineers distributed around the United states who are on 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> call and must be able to respond to service needs in a matter of minutes, not days.
Process downtime costs can run in five-figure amounts per hour (tens of thousands of dollars per hour). Shutting a manufacturing line down for three days before it can be fixed is intolerable and could put a producer out of business.
- 2. Many of our clients (general licensees) have "resident" ABB Process Automation engineers at their facilities.
That is, the radiologically trained ABB service engineer(s) works directly for the client full time, along with their regular operating personnel.
His/her duties involve continuous monitoring and preventative maintenance of the precision gauging and control system.
He/she responds instantly to perform the type of service envisioned in the proposed 31.6(f) thereby minimizing or preventing process downtime.
This approach has been highly successful over the past 40 years and demonstrates the highest level of safety and manufacturing efficiency through the dedicated use of trained experts.
650 Ackerman Road P.O. Box 02650 Columbus, Ohio 43202-1502 ABB Process Automation Inc.
Telephone:
6141261-2000 Telex:
Telefax:
246675 APR 1 5 19~ 614/261-2172 Acknowledged by card "......,_,,.tffinf,,._
U.S. NUCLEAR REGULATORY COMMISSlu~
DOCKETING & SERVICE SECTION OFFICE OF THE SECRfTARY OF THE COMMISS:ON Document Statistics
USNRC 3/9/92 Page 2
- 3. Installation and relocation of large measurement (gauging) and control systems can take many days to many weeks from " * *
- the start of activities *** " until the sealed sources are permanently installed, all operational safety features are verified, the final site surveys are completed, and operators are trained before turning the system over to the client (general licensee). These radiological tasks are all handled by our trained installation and service personnel at appropriate times in the sequence of events while working in harmony with the client's project manager, electricians, plumbers, fitters, and other mill personnel.
- 4. We understand your desire to do ". *
- a level of periodic inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded source." However, it is not practical or reasonable to give three days advance notice and a schedule of when such an event might occur.
As a specific licensee, our workers are trained and certified in the radiological activities t hey perform. They are monitored and their exposure records are reviewed routinely.
Our clients (general licensees) do not have much occasion to be in direct contact with a device which is typically a subsystem within a larger measurement module.
Regardless, the devices have been designed, registered, licensed, and applied in accordance with 10 CFR 32.51 and 10 CFR 31.5 so that they are safe for use by generally licensed users.
Again, many years of experience and the monitoring of general licensee's actions through observations by our service and resident engineers shows the general license program is highly successful in protecting the health of all workers and minimizing danger to life or property for all of the devices we distribute.
We request that you consider how impractical a three day advanced notice is for these vital service operations which are routinely performed by radiologically trained and licensed experts.
A three day wait would normally cause severe productivity losses and economic harm.
Such a wait would not alter or improve upon any safety considerations.
It makes no sense to impose such restraints on American industry.
We respectfully request that the three day advance notice condition be dropped from further consideration in the proposed rule.
Sincerely,
£~ager Nucleonics and Radiological Operations
DOCKET NlJ,.,..)CH PR PROPOSED RULE p f i3. ;;_. -!,.. LTR8 6 *DOC) ti"' Fl< I al!,)
- 0CKt1 t.D LCIRAL DATE: February 11 Y5~~92 Control Systems
- 92 MAR 16 AlO :06 Kennedy Drive Archbald, PA 18403-1598 (717) 876-1500 Fax: (717) 876-4865 LETTER TO: Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch
SUBJECT:
Comment to Proposed Changes CC:
L. Morgan
REFERENCE:
Federal Register; Vol 56; NO 249; 12/27/91
Dear Sirs:
I wish to make the following comments regarding your pro-posed changes for general licensees (10 CFR Parts 31 and 32).
We are a manufacturer of Isotope thickness gages, and the proposed changes could have an adverse effect on our business.
- 1.
10 CFR Part 31.6 (f) will state that persons performing service on a generally licensed device shall notify the appropri-ate Regional Office of the NRC "at least 3 working days prior to engaging in such activity".
Our equipment is installed on steel and aluminum rolling mills.
If the equipment fails, 3 days would be an unacceptable down-time before the problem is resolved.
The NRC should specify an alternate procedure for "emergency service".
- 2.
I believe that the NRC estimate of 20 minutes (costed at
$10.00) seems very optomistic.
During a recent mailing of an NRC questionaire, I was contacted by approximately 20 of our custom-ers to "talk them through" the questionaire.
I would anticipate many similar sessions whenever the periodic notice arrives at our customer's desk.
In many cases, the burden falls back on the manufacturer.
- 3.
10 CFR Part 31.5 (c-ii) states that the customer will period-ically fill out a report which includes "who has performed what service on the device since the last report".
~his may represent a period of "1 to 3 years".
Again, I anticipate that this burden of researching service reports to obtain a chronological service report will in many cases fall on Loral's field service department.
Many of our customers (such as steel service centers) do not have a electron-ics maintenance department with maintenance records.
Again, this will increase Loral's cost of doing business.
1 APR 15 1992 Acknowledged by card""
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- 4.
10 CFR Part 32.Sla (para c) states that the vendor will furnish instructions which include "disposal option including possible costs".
As you know, the northeast regional compact does not presently have a high-level radioactive waste disposal facility.
AM241 is classified as high-level waste.
We have been quoted prices as high as $30,000 for a single 1 Curie Sealed Source Capsule.
What are we supposed to give as a possible disposal cost 10 years from now (the typical life of our equipment)?
2 Sincerely, g~,;v&
J ohn E. Gilchrist Radiation Safety Officer
DOCKET NUMBER PROPOSED RULE PR 3 I DEPARTMENT OF THE NAVY OFFICE OF THE CHIEF <P. (rM:~.t_l-J OPERATIONS WASHINGTON, ocU~Hiiio-2000 Secretary U.S. Nuclear Regulatory Washington, DC 20555 "92 NAR 13 P4 :07 tiff ICE OF s* CRETA1~Y ilOCK[i ING,., Sf-iNICf" BRANCH Commission ATTN:
Docketing and Service Branch
Dear Mr. Secretary:
cs-,r IN REPL Y REFER TO 5104 Ser 455/20601736 12 Mar 92 This letter concerns the proposed rule, 10 CFR Parts 31 and 32, Requirements for the Possession of Industrial Devices Containing Byproduct Material, published in the Federal Register, Volume 56, No. 249, Friday, December 27, 1991.
The 30-day time limit in Section 31.5(11) to respond to an NRC verification request is too short.
The Navy holds over 2,500 generally licensed devices (gas chromatographs, explosive vapor detectors, and helicopter inflight blade failure indicator systems) installed in transportable devices which do not or may not remain in fixed geographical locations and are often located remotely from the Navy office that will have to respond to the Nuclear Regulatory Commission (NRC) verification request.
A 30-day time limit will result in numerous unnecessary violations.
The average time of 20 minutes estimated by the NRC to prepare a response to their verification request is low for the Navy.
The Navy could have to answer over 3,ooo verification requests per year depending on the frequency of requests and worst case method of implementation (one letter per device per year).
The administrative effort would be a significant burden to assure compliance and accountability of generally licensed devices.
Industrial devices which are generally licensed under 10 CFR 31.5 include numerous types of sources from gas chromatographs and portable detectors containing small amounts of low hazard nickel-63 and tritium to fixed gauges containing curie amounts of cesium-137 and cobalt-60.
Public health and safety may be served by adopting measures to preclude incidents with larger sources.
However, as we have demonstrated the proposed rule creates an unnecessary administrative burden and potential for unnecessary violations for late responses to NRC requests which do not protect public health and safety.
This is particularly true for sources that do not require reporting as lost or stolen under 10 CFR 20.2201 and do not require leak testing.
APR 15 1992 Acknowledged by card nH-HffWIIHffW... hffh
U.S. NUCLEAR REGULATORY COMMIS IOt-.
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE CO. Ml ION Oocu'lle'lt Slalistrcs Postmark D te _
Point of contact on this matter is Captain James w. Malinoski who can be reached at (703) 602-2568.
Copy to:
USNRC Region II CMC (LPO-1)
COMNAVAIRSYSCOM (AIR-54042K)
COMNAVSEASYSCOM (SEA-06GN)
NAVSEADET RASO sincerely, J
ES W. MA~ N KI Captain, MSC, USN Executive Secretary Navy Radiation Safety Committee
Amersham Corporation 2636 South Clearbrook Drive Arlington Heights, Illinois 60005-4692 (312) 593-6300 LCCKET ED USMRC
- 92 MAR 12 P 5 : 1 0 March 11, 1992 Secretary U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville MD 20852
Dear Sir:
Amersham
([})
I am writing on behalf of Amersham Corporation to respond to NRC's proposed rule on Requirements for the Possession of Industrial Devices Containing Byproduct Material, 10 CFR Parts 31 and 32 which was published in Federal Register Vol 56 No 249, Friday, December 27, 1991 Pages 67011-67017.
Amersham Corporation supplies a wide variety of radioactive materials throughout the United States, and including Static Eliminators which are generally licensed devices that are leased to our customers.
The following are our comments on the proposed rule:
- 1.
Agreement States Compatibility N RC is proposing Division 2 level of compatibility which means Agreement States address the provisions in the NRC Regulations without using identical language, and may adopt more restrictive requirements than NRC.
We are strongly in favor of total or strict compatibility.
There is already considerable variation state-to-state in the regulations controlling generally licensed devices. Some states require the recipient of a generally
-.i.S. NUCLE/,R REGULATORY COMMISSIOt--.
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document St.. * ~
Postmark Data (A -P 5 Copies Received __
Add'I Copies Reproduced _'3....,,.,..---=c---
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Secretary March 11, 1992 Page 2
- 2.
licensed device to report to the state within 1 o days, the fact that they received such a device. Some states charge the general licensee a fee, some annual, others a one-time fee. Other states do not charge fees.
This variation in the regulations makes it very difficult for a nation-wide supplier of generally licensed devices, such as Amersham, to provide general licensees with advice on their responsibilities as general licensees.
With total or strict compatibility, suppliers could provide specific and definitive advice.
Consequently, Amersham is very much in favor of Division 1 Rules of Compatibility.
Reports to NRC by General Licensees There is a distinct possibility that the reporting requirements could deter general licensees from purchasing a generally licensed device. In the preamble to the proposed rule, it is estimated that the cost of reporting would be on the order of
$1 O per device which is approximately 10% of the cost of some inexpensive devices e.g. some of the static eliminators supplied by Amersham.
- 3.
Static Eliminators There is a wide variety of generally licensed devices, from static eliminators containing millicurie quantities of Polonium-210 to devices containing considerably larger amounts of Cesium-137 or Americium-241. Amersham questions whether it is appropriate or desirable to cover such a wide range of activities under the same regulation.
There is a further distinction for Static Eliminators and that is the fact that they are leased and not sold.
Since the term of the lease is for 1 year, we question whether Static Eliminators need to be subject to these reporting requirements by general licensees. The eliminators are returned to the manufacturer /distributor at the end of the lease period of 1 year.
Secretary March 11, 1992 Page 3 Therefore,Amersham requests that Static Eliminator, Model Number PDM.1002Hn, Registration I L-136-D-333-B be exempt from the reporting requirements by general licensees in the proposed rule. Information on the distribution of Amersham's Static Eliminators will still be available to NRC and Agreement States via the Quarterly Reports filed by Amersham Corporation.
In summary, Amersham first of all favors complete compatibility between NRC and Agreement States on rules and regulations applicable to generally licensed devices.
Secondly because static eliminators are leased and not sold, and the lease period is 1 year, we request that they be exempt from the reporting requirements by general licensees.
Amersham thanks NRC for the opportunity to comment upon the proposed rule. Please let us know if you have any questions or require any clarification of the information we have provided. I shall be pleased to discuss them with you and may be reached by phone at 708/593-6300, extension 379.
Sincerely, ryan W. Baker, Ph.D.
Manager, Environmental and Safety Regulatory Affairs BWB/ cem
PROPOSED RULE_
~ I'
~ b f R. b ? OJ -4ERTHOLD SYSTEMS, INC.
- .. *t*
- t'. i1 Proceu Control lnatrumenta t.., LI \\ - l
- USN f< C HopeweD Business & Industrial Parle 101 Corporation Drive Aliquippa, Pennsylvania 15001-4863
,92 MAR l 2 p5 :13 Telephone: [412) 378-1900 11 Telefax: [412) 378-1926 Telex: 988393 [8RTHLD SYST UD)
March 5, 1992 Secretary U.S. Nuclear Regulatory Conmission washington, o.c.
20555 Attn: Docketing & Service Branch Gentlemen:
As a distributor of devices used under the general license in 10 CFR 31.5 and the equivalent general licenses in the Agreement States, I am pleased to have the opportunity to comnent on the proposed amendments to 10 CFR Parts 31 and 32, published 12/27/91 as 56 FR 67011.
We believe the primary objectives of the proposed amendments are to (1) enable effective cormunlcation between the U.S. NRC and the users of the general license in paragraph 31.5, and (2) to assure that the users are informed of diposal options, including costs.
We believe that these objectives could be acconplished by a sinple amendment to paragraph 31.5 which clearly states a requirement for the general licensee to respond pronptly to reasonable information requests form NRC. If the distributor of the device anticipates that NRC will contact the general licensee and may mention possible disposal costs, you can be assured that the distributor will have discussed the matte with his customer. A "hidden cost", if first revealed t o the user by the could destroy any chances for additional sales to that user.
Thank you,
..,,,-0 G.H. (Bud) Smith, Jr.
President, Berthold Systens, Inc.
cc: Tom Kuny, RSO Jeff Dinkel Assistant RSO APR 15 199 Acknowledged by card """'"""".....,.
1
U.S. NUCLEAR REGULATORY COMMISSIOt-.
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date 3
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PROPOSED RULE 3
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(5'F~,1aly March 9, 1992 "OCI\\EilO
~. USNRC CORPORATION "fl 11AR 12 A10 :l9 secretary U.S. Nuclear Regulatory commission Washington, D.C. 20555 Attn:
Docketing and Service Branch
Reference:
Proposed Rule Change Gentlemen:
10CFR Parts 31 & 32 RIN 3150 -
AD4 Federal Register Vol. 56, no. 249 Friday, December 27, 1991 As a small manufacturer of gauging devices distributed to General Licensees, we have a number of comments.
First, to establish a baseline for our comments, we maintain an NRC license which permits the distribution of certain products to General Licensees.
We also maintain an Agreement State license for another facility which permits the distribution of certain other products to General Licensees.
In addition, we maintain another NRC license under which, among other things, our field people operate.
- Finally, we maintain reciprocity agreements with most agreement states.
Now, our observations by paragraph:
General -
We have no objection to these being items of compatibility, if our proposal on 31.6 is adopted.
31.4 31.5(b) 31.5(c)(ll)
If not, our jobs become more complicated and our costs skyrocket with no evidence of improved safety to show for it.
No comment We have no objection to deleting the Agreement State reference provided this is not a prelude to taking away the Agreement State Authority to register products for distribution to all General Licensees.
We agree that the NRC ought to have more oversight of General Licensees, and we have no problem with the NRC requiring information from them.
However, we must point out that these things are not done in a vacuum and that there are economic consequences, two of which come immediately to mind.
First, our equipment is sold in direct competition with non nuclear gauges.
About one third of our unit sales are to APR 15 1992 ~
Acknowledged by card"" ""'"""'"lfilm~
THE OHMART CORPORATION
- 4241 ALLENDORF DRIVE, CINCINNATI, OHIO 45209 * (513) 272-0131
- TELEX: 21-2071 OHMUS.A:-UR
U.S. NUCLEAR REGULATORY COMMISSIOI-DOCKETING &: SERVICE SECTION OFFICE OF THE SECRETAA¥ OF THE COMMfSSION Document Stattstiet Postmatk Date --3_,,j-f...... q _____ _
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31.6 General Licensees and the principal reason is that they simply will not tolerate the cost and the perceived hassle of a specific license.
We realize that the reference publication says fees will be addressed separately, but everyone must be aware of the basic tenet of economics that the more something is taxed the less of it you get.
The recent NRC fee increases caused 1000 licenses to be cancelled.
Anything more than a token fee could wipe out a significant part of our business.
Second, the referenced document says that the NRC will contact both new and old General Licensees to request the information.
If you rely on the quarterly reports for that, we have no objection.
However our experience has been that, even without your "enhanced oversight," we are repeatedly asked for information about General Licensees that we had already supplied on the quarterly reports.
In one case, we were told that several General Licensees could not be found and were asked to search our files.
Instead, we searched the phone book, as the agency could have done.
One was a Municipal Waste Water treatment plant.
All were easily found.
If manufacturers are asked to perform this kind of service, there must be compensation provided.
The only issues raised in this proposal which are different from what we have already been doing for many years have to do with the 180 day limit and the three day notification.
We have no objection to the 180 day limit.
We do have a problem with the notification language with respect to time.
Our situation may be unique in that, while most of our units come from an Agreement State, the people who perform the field work continue to be under our NRC license and, therefore it appears that we have no field work reporting obligation under these paragraphs.
However, our experience with reciprocity in most Agreement States indicates that, while some field activities allow for three day notification, many do not, and so we believe the language should provide for variations other than emergencies.
Our Field Service Engineers are on the road 80% of the time or more, so that scheduling becomes a problem and a three day notice a burden.
In addition, something over 95% of our service calls involve electronics, with only a brief concern for the source holder.
With respect to these service calls, any substantial
32 *.52 involvement with the source holder is unpredictable, so we don't know until we get there, if the call would have required reporting.
We propose the following:
- 1.
Since startup and decommissioning/disposal are predictable, that three day notice is reasonable.
- 2.
Other service calls are not predictable either in timing or in content, and so we propose either:
- a.
No reporting
- b.
Same day or after the fact reporting.
- 3.
In all cases, fax reporting should be acceptable.
ey adopting the proposal the NRC will be guaranteed that activities reported under the three day notice will involve the source holding mechanism, occupancy evaluation and similar radiation related matters.
Inspection time will not be wasted on what will in all probability turn out to be an electronics service call.
We have no problem with the general concept.
- However, we have a considerable problem with the idea that you expect it to be the responsibility of the specific licensee to identify the responsible person at the user's site.
We have already tried to do that, but we have no control over any other licensee, so we can only accept what the licensee tells us.
We should be responsible to accurately report what we are told, but it must be the regulators' responsibility to oversee the input accuracy of such information.
Finally we agree that sending in a report will not impose any significant hardship on a General Licensee.
In fact, it is our opinion that knowing the NRC is both aware of, and cares about, the equipment will substantially improve performance and we believe the correspondence program should be implemented and measured against previous records for a year or two before any enhanced inspection program is started.
It may not be necessary.
GWB:ss Very truly yours, c:;;~,cP', ~
George W. Brown Radiation Safety Officer
DOCKET NUMljtt1 PR 3 f 3 ;;
PROPOSED RULE ( 5 I, F £ tfi1}
MCDONNELL DOUGLAS McDonr_5" ~
Ci'g§'27Y MKL-054-92 Secretary United states Nuclear Regulatory Commission Washington, OC 20555 Attention: Dcx:::keting and Service Branch
Dear Sir or Madam:
McDonnell Douglas Corporation has the following comments in response to Nuclear Regulatory Cormni.ssion's (NRC) proposed rule for 10 CFR Parts 31 and 32 p.lblished in the Federal Register of 27 December 1991.
10CFR 32.310 requires the licensee to sul:Jni.t the nane of the person responsible for generally licensed devices at the using facilities.
Who (l:uyer or seller) determines who this responsible person is? Being a large CX>rporation, we would prefer that someone from the Safety Department be identified as the responsible person. '!his would allow cxmtinuity.
We would also recammend adding the Purchase Order Number to the infonnation requested on Sutpart E.
Knowing the Purchase Order Number \\oX)fild si.Irplify locating any generally licensed devices we would µirchase.
Another CX>ncem we have is that generally licensed devices are difficult to identify because the manufacturer places the caution label at an inconspicuous location. For example, the caution label and serial number for one type of self-luminous sign we possess are located on the tack of the sign. 'lhe tack of the sign is installed on the wall. M:>reover, the label cannot be seen mrt:il the entire sign is renr:wed from the wall. 'lhe exchange of tritium vials does not require renmring the tack of the sign from the wall. Another CX>ncem we have regarding self-luminous signs is being able to maintain the nane of the responsible user. 'lhe maintenance departments in our various bri.ldings are responsible for these signs. ~er, the specific employees responsible for these signs can change frequently making the maintaining of a current list of the responsible users hlrdensame.
10 CFR 32.52 requires the licensee to report transfers of generally licensed devices to the NRC.
We request that these licensees also be required to report transfers to the safety departments of companies receiving the devices.
'lhe employee who receives the 10 CFR 31.51a (c) infonnation may not necessarily report the receipt to the safety department or pass along the information to the sul::sequent responsible user.
'!hank you for the opportunity to comment.
Sincerely, d~
Lisa R. Jenkins Radiation Safety Officer McDonnell Douglas Corporation Dept 064B, Bldg 4, M: 0012491, (314) 234-9092 IRJ:mkl
.APR 15 1992 Acknowledged by card............ "'""""'""'""'
P.O. Box 516, Saint Louis, MO 63166-0516 (314) 232-0232 TELEX 44-857
U.S. NUCLEAR REGULATORY COMMISSIOt-.
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Stctistics Postmark Date fr~
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SOLON TECHNOLOGIES,.1.~C.
( ~' f ~ ~ 1 O /6~01 Cochran Road Solon, Ohio 44139 Phone: 216/248-7400 Fax: 216/349-6581 HARSHAW/QS CRYSTAL AN D DOSIM~Tt':)~eucTS FEDERAL EXPRESS Secretary
'92 HAR 11 P4 :14 March 10, 1992 U.S. Nuclear Regulatory Commission Washington, D.C.
20555 Attention:
Docketing and Service Branch (j)
RE:
Comment on proposed rule for Requirements for the Possession of Industrial Devices Containing Byproduct Material (RIN 3150-AD 34)
Dear Sirs :
After careful consideration and analysis of the above referenced proposed rul e, Solon Technologies, Inc., feels that it is necessary to provide this written comment.
Specifically, we consider the proposed Section 32.52(b) to be unnecessarily burdensome.
To send a quarterly Transfer Report to an Agreement State indicating that no byproduct material was sent by a particular facility to that Agreement State adds additional paperwork to the process but does not enhance the monitoring of generally licensed byproduct material since transfers of these materials are already required to be reported.
Solon Technologies, Inc., proposes that the wording of Section 32.52(b) be changed to read, or similarly read:
If no transfers have been made to persons generally licensed under §31.5 during the reporting period, the report must so indicate if requested by the Agreement State agency.
Solon Technologies, Inc.,
appreciates the opportunity to submit this comment and hopes that the Commission will give it serious consideration.
Sincer ely,
~
~\\:nnedy U Mgr. Environmental Affairs JLK:cjs APR 15 1992 Acknowledged by card"'"
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"'"'"'""'""'"lffil
u LA, i.:A nt: 'ULATORY COMMISSIOt.
DOCKETING &,SERVICE SECTION OFFICE OF TI-JE 5ECRETARY OF n E COMMISSiON Docum£nt ~1-"*t ~
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March 6, 1 992 Secretary, U.S. Nuclear Regulatory Commission Washington, D.C.
20555 Attn:
Docketing and Service Branch Gentlemen:
The NRC published proposed amendments to 32 on December 27, 1991, at 56 FR 67011.
relate to the draft regulatory analysis, is referred to in the notice of proposed s,F,701!)
COCKLiCO USNHC
- 92 HAR -9 A11 :13 10 CFR Parts 31 and The following comments dated June 1991, which rulemaking.
- 1.
General comment -
The proposed rule includes changes which are not discussed in the draft regulatory analysis, e.g., a new requirement for certain persons to notify NRC before servicing devices used under the general license in 10 CFR 31.5.
Furthe r, the regulatory analysis and the FR notice s hould be reconciled with respect to data pertinent to costs of the rule and with respect to use of a format for reports.
- 2.
Two additional alternative actions which reasonably should be addressed in the regulatory analysis are:
(A)
Revise §31.5 to provide for registration by the general licensee like is done in §31.11 and in 10 CFR 40.25.
(B)
As a matter of compatibility, require the Agreement States to regulate their specifically licensed dis-tributors like NRC regulates its distributors.
This would result in the Agreement State distributors sub-mitting quarterly reports to NRC of transfers to
§31.5 general licensees.
It is likely that most of the Agreement States currently regulate in this manner.
Such regulation would be consistent with C.22(d) of the "Suggested State Regulations for Control of Radiation. "
- 3.
At page 2 of the draft regulatory analysis it is stated that the general licensee must report a transfer to the Commission within 30 days of the transfer.
There is an important exception to this requirement which is not noted.
No report is required if the device is transferred to the specific licensee in order to obtain a replacement device.
This exception is important in attempting to reconcile the number of devices possessed at any one time by general licensees with the number of devices transferred to general licensees.
1 -
Acknowledged by cai APR 15 1992
U.S.,v,~
- AR REGULATORY COMMISSIOI\\
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMM1ss;oN Document Statistics Postmark Date 3 7
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Copies Received __, _____ _
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- 4.
At page 3, lines 3-5.
It is stated that "... discarded devices can result in an insignificant but unnecessary exposure of the public... "
It is not explained why the NRC is concerned about insignificant exposures.
Perhaps a more appropriate char-acterization would be "... discarded devices can result in poten-tially significant and unnecessary exposure of the public... "
- 5.
At page 3, lines 9-12.
The statement that the current regulations do not provide any procedure for assuring that the general licensee complies with the rules and regulations for proper use and disposal, is apparently fundamental to the argument that the proposed rule change is needed.
This statement, however, overlooks the provisions of 10 CFR 31.2 and 10 CFR 30.52.
These provisions should be carefully considered when revising the draft regulatory analysis and explaining the need for the rule changes.
- 6.
At page 10, lines 2-4.
In discussing the regulations of the Agreement States it is stated that "... there is no uniform require-ment equivalent to the requirement in 10 CFR 32.52 that transfers be reported to NRC."
In view of C.22(d) of the Suggested State Regulations, this statement is surprising.
However, assuming it to be a valid statement, the matter could be remedied by making it a matter of compatibility (either as Division 1 or Division 2) for the States to conform to 10 CFR 32.52.
- 7.
At pages 13, 14 and 27.
It is suggested that implementation of the proposed amendments may avert $750,000/year clean-up costs.
This statement seems poorly supported.
It is noted in the FR notice at 56 FR 67012 that "... many of the States already have accountability programs in place."
But, all the incidents (except 1) listed in Table-1 at page 13 and commented on at page 14 occurred in Agreement States.
The one exception, involving Thorium in PA, does not relate to these proposed amendments to Parts 31 and 32 for byproduct material.
Further, the text does not indicate how many of the reported inci-dents involved devices that were used under general license.
Were they perhaps used under specific license?
- 8.
At page 28, it is indicated that no significant implementation problems are expected.
"The only action needed... mail an informa-tion notice to specific licensees to inform them of their new responsibilities. "
This conclusion seems to overlook the submission to NRC Regional Offices of many reports of intent to service devices and NRC's processing of those reports.
Also, the new requirements will require NRC inspectors to go to distributors in Agreement States in order to determine compliance with the requirements.
Will NRC 2 -
assess fees for such inspections?
If no fees are assessed, are those distributors receiving different treatment than is given to NRC's comparable specific licensees by NRC or by the States?
Further, the proposed rule seems to say that NRC will no longer be dependent upon the States' safety review of devices.
If this is the intent, NRC will need to staff up with several specialized technical reviewers to handle the additional work load.
cc:
Joseph J. Mate, NRC 3 -
Sincerely, P~tl P_.m Donovan A. S~Esq.CHP 4821 Bel Pre Road Rockville, MD 20853
DOCKET NUMBER PROPOSED RULE PR 3 / 1 3 ~
~b ('(? b 70,-v l OCKL rm
~ 00(() INC.
2937 Alt Boulevard North, Grand ls1~~~1~ w York 14072-1292 Telephone: (716) 773-7634
- 92 MAR _FifX ~1~7~w73-7744 Docketing & Services Branch Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Ref.
Proposed Rule Change RIN 3150-AD34
Dear Sir:
We strongly feel that the proposed rule change to 10CFR31 should not be approved as promulgated.
The vast majority of generally-licensed devices contain small amounts of isotopes which emit no penetrating radiation, and additionally have relatively short halflives, thus presenting neither exposure risk nor long-term environmental risk.
For example, most devices used for the control of static electricity contain only 10 or 20 milliCuries of polonium-210; none contain more than 200 milliCuries.
Since polonium-210 'has a short, 138-day halflife, and emits no measurable penetrating radiation, these devices pose virtually no hazard in the unlikely event of loss of accountability.
The worst-case incidents referred to in the Federal Register involved long-lived isotopes with emitted significant penetrating radiation.
We strongly urge the Commission to consider a revision to 10CFR31 establishing two separate classes of generally-licensed devices.
Class A, for devices posing little risk to persons or the environment if los t, and Class B, for devices posing high risk.
This separate classification achieves the following:
- 1.
Class A devices would not be subject to the follow-up program outlined in the proposed new regulations, thus minimizing the cost to the general licensees, and therefore to the economy, for a project which the NRC admits will not have any significant safety benefit.
- 2.
Class B devices would be subject to the follow-up program outlined in the proposed regulations, thus allowing the NRC to concentrate its efforts on tracking those devices defined as high risk, while simultaneously minimizing the cost to the NRC.
A SUBSIDIARY OF MARK IV INDUSTRIES INC.
APR 15 1992 Acknowledged by card..... tn,nmrnnn,m,
U.$ NUUEAri R GlJL TOr Y C:UM\\1 S 10, DOCKETING & SER IC!: SECTION OFFICE OF THE Sc CR_ TA OF THE COMMISS N Docur,e, t Sta ish Postmark Date ~ _ lf-1_ ?-
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In summary, the proposed changes to 10CFR31, would pose an unnecessary financial cost, estimated by the NRC to be
$6,000,000 for the general licensees, for a program which the NRC admits has no significant safety benefit. It should be noted that the NRC estimate of $10 per device represents as much as 10% of the purchase price for some devices.
No mention of the financial impact on the NRC's budget appeared in the proposed rule change.
This cost is also significant, and cannot be ignored.
The approach we have outlined above achieves the same end with a much lower cost to the economy, and to the NRC's own limited budget.
Sincerely yours, ef)__:J?rJ~
a_ '. David McG r aw Vice-Pr e sident General Manager N RD INC.
"92 t1AR -9 A11 :14 The Quaker Oats Company. P.O. Box 3040. Shiremanstown. Pennsylvania 17011 (717) 737-8601 uFf !CE' OF SECKE fAt~** (!)
March 4, 1992 DOCKETING t. '.ii t,v,cr BRANCH Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn:
Docketing and Service Branch
Dear Sirs:
We strongly oppose the proposed licensing revision to 10 CFR 31.5 as per the Federal Register, Vol. 56 No. 249, Friday, December 27, 1991, Proposed Rules.
We fully understand the importance of controlled access and correct disposal of these said gauging devices.
The single device in our facility is clearly labelled as a radiation source.
The device is understood and respected by our operating and maintenance personnel.
We have positioned such that we should not service, relocate, or dispose of this device without contacting the manufacturer.
We depend on the manufacturer to possess the technical knowledge and skills to maintain the equipment and license.
Finally, we see no advantage to adding a reporting/licensing burden to users such as ourselves.
Adding direct license responsibility to Quaker Oats does not provide any additional protection from unauthorized disposal.
We already have a responsible posture toward protecting our employees and the general public.
Respectfully submitted, Norman P. Russell, P.E.
Manager, Engineering/Maintenance APR 15 1992 Acknowledged by card.................,..,,,m,.:;;
. _. c.GuLAiOR 'COM,11SSIO~
OCGKETING & SERVICE SECTION OFFICE OF T!-<E SECRETARY OF THE COMMISSION Document St;,*stics Postmarl< Oat 3 5 Copies Recei~,ed __
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DOCKc:, NUMBER OOLl',Li LO USNHC February 29, PROPOSED RULE PR '3 I 3 ~I) r 5, rf!.., 1'.!.1/
1992
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°92 tU\\R -6 p 3 :26 OFF!Cf_ ~.. 5f Cfl:tf{-
COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENERGy0,octr:(,,.r/tJ c'fucRE")
ON PROPOSED RULE, "REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL," 56 FED. REG.
67011 (DECEMBER 27, 1991)
OCRE supports this proposed rule.
This rule should accomplish the goals of preventing loss of accountability for such devices and of ensuring that users of these devices have a greater understanding of the hazards of their improper use, transfer, or disposal.
The need for this rule is compelling, given that some of the worst radiological contamination incidents have occurred due to the improper handling and disposal of byproduct materials intended for use by materials licensees.
With regard to Agreement State compatibility, OCRE finds the proposed categorization of this rule as a matter of Division 2 level of compatibility to be appropriate.
The Federal Register notice states that the NRC intends to periodically send notices to general licensees requesting verification that they still possess the device and reminding them of their regulatory responsibilities.
It is stated that the frequency of these notices may range from 1 to 3 years.
OCRE believes that these letters should be sent annually; any less frequently runs the risk of losing accountability of a device.
Three years is too long to wait to learn that a device has been lost.
The provision of an interim enforcement policy is appropriate to remove any disincentives to identify deviations.
This proposed rule should be adopted without delay.
Respectfully submitted, Susan L. Hiatt Director, OCRE 8275 Munson Road Mentor, OH 44060-2406 (216) 255-3158
\\
APR 15 1992 Acknowledged by card ntttlfffftHHftlHIHlh~
I U.S NUCLEAR REGULATORY COMMISSlO~
DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ------
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DOCKET NUMBER PR 3 I PROPOSED RULE 3 2.
(:'Ff.( ' 10 I_!) UOGK[ilO February 2 8, 1992 USNRC Secretary, U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn:
Docketing and Service Branch Gentlemen:
'92 NAR -3 P 3 :04 The following comments concern the NRC's proposed rule to revise requirements for devices used under the general license in 10 CFR 31.5.
The proposed rule was published 12/27/91 at 56 FR 67011.
- 1.
Regarding compatibility:
A Division 2 level of compatibility may adequately serve health and safety purposes; however, a Division 1 level may also be justified.
Distributors of devices used under 10 CFR 31.5 and equivalent Agreement State regulations operate throughout t he U.S.
A Division 1 level categorization may l essen the administrative burden for the distributors by re-ducing the potential for differing requirements.
For example, the proposed §32.52 (b ) requires a quarterly report to the State that identifies the Person Responsible for Control of the Device."
The State may prefer identification of the "individual by name and/or position who may serve as a point of contact."
Would the distributor be required to submit two reports?
Further, if Division 2 level, would a State need to require its distributor to inform customers of disposal options and costs?
2.
The Discussion portion of the Supplementary Information refers to the "... registration and verification system contained in the proposed amendments... "
It also states that "... if older sources are transferred... the registration system is intended to capture them."
Is it correct to conclude that this proposed amendment is intended to provide a means of tracking each source as well as a means of identifying each general licensee?
If so, what is the justification for tracking each source?
Is similar tracking planned for sources used under specific license?
- 3.
The Discussion portion of the Supplementary Information states
"... the current regulation, 10 CFR 31.6, is not clear with respect to time restrictions."
I believe that statement is subject to question.
There is no time restriction attached to the general license provided in 10 CFR 31.6.
There is a time limit attached to the general license provided in 10 CFR 150.20 (see §150.20(b)(3)).
1 -
Acknowledged by card "~~~"L?... :.~
U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Stap~ties Postmark Date 3 :).
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Copies Received ______ _
Add'I Copies Reproduced _3 __
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- 4.
The Discussion portion of the Supplementary Information states that: (1) there are about 600,000 devices used by 35,000 NRC general licensees, (2) there are an estimated 70,000 Agreement State general licensees, and (3) the Commission has estimated the amendments to cause licensees an additional cost of $10 per device.
Accordingly, an assumption that the States have twice as many devices as NRC produces a cost to all licensees of
$18,000,000 per year or every 3 years.
The safety record related in the Discussion would not appear to justify imposition of such a burden on industry, particularly since steps have been taken to avoid Auburn Steel-type incidents.
Thirty three years of extensive and apparently excellent health and safety experience with this general license would seem to support serious effort to reduce this $18,000,000 cost.
It shoul d be noted that this $18,000,000 is perhaps low because it is based on a total of 20 minutes for the licensee to maintain adequate records and respond in writing to NRC questions.
- 5.
The proposed language used to amend §31.5(b) and §31.6 raises a question as to what specifications app l y to the devices.
At present, a device manufactured in an Agreement State and used under §31.5 must satisfy the State's specifications for devices distributed to its own general licensees.
With the proposed language, the devices need not be acceptable for use under general license in the Agreement State.
The proposed language merely requires that the device be as described in §31.5, and that appears to mean §31.5(a) which requires that the device be "designed for the purpose of detecting, measuring... light... "
- 6.
In the proposed §31.5(c)(ll) the general licensee is directed to "verify" certain information.
I respectifully suggest that the general licensee may be asked not only to "verify but also to supply certain information.
The information called for in §31.5(c)(ll)(iii) appears to represent a departure from normal NRC practice of holding the general licensee responsible for complying with NRC regulations.
Is the general licensee no longer the responsible "person"?
- 7.
Proposed §31.6 appears to tighten NRC control over devices distributed by a manufacturer located in an Agreement State.
Since such distribution to §31.5 general licensees apparently would be authorized only pursuant to the NRC's general license in §31.6, would transfer of an out-of-specification device be the concern solely of NRC?
- 8.
Proposed §31.6 appears to allow the general licensee (§31.6) to perform a wipe test for a generally licensed (§31.5) user only if the §31.6 general licensee supplies a copy of §31.~.
It may be reasonable to require a copy of §31.5 to accompany transfer of the device, but it may be unnecessary paper work at other times.
2 -
- 9.
Proposed §31.6(e) requires the providing of instructions to the individual responsible for service... "
Is not the general licensee (§31.6) the primary responsible party?
- 10.
Proposed §31.6(f), last sentence, should be clarified with respect to when prior notification is not required.
Must ' a radiological hazard accompany the malfunction in order to be exempt from notification?
It should be noted that many calls for service by manufacturers are for emergency service.
A gauge may malfunction and until it is repaired, production stops and workers may be sent home (with or without pay).
To require 3 days prior notice in such circum-stances, where the user is not allowed to repair the "black box",
does not appear justified.
Does experience indicate a need for this change?
If experience does show a need for some notification to the Regional Office, could a lesser period than 3 working days suffice?
- 11.
Proposed §32.51a(c) would require the §32.51 specific licensee to provide written instructions about servicing to the user of the device and perhaps to a competing service group (( §31.6(d)).
Would it suffice for the §32.51 specific licensee to instruct that servicing must be performed by a specific licensee?
- 12.
Proposed §32.52(a) requires each person licensed under
... §31.6" to submit quarterly reports, even if no transfers are made during the quarter.
The regulatory scheme is not clear about how NRC will identify the §31.6 general licensees who fail to report zero transfers.
Will this be a cooperative effort with the Agreement State specific licensing authorities?
- 13.
Proposed §32.52(c) would require that records be maintained for 5 years after the date of the recorded event.
This would appear to be an excessive period since the event would have been reported to NRC in the appropriate quarterly report.
A period of 3 years, as normally provided by §30.5l(a)(2), would appear sufficient.
Further, what disposition of the records is expected if the specific licensee goes out of business?
- 14.
Proposed §32.310 is titled "Subpart E -
Report of Transfer of Byproduct Material."
If a vendor replaces a source at a user's facility, is that action to be reported on this form?
3 -
~
ncerely, ~
~"-
onovan A.
th, sq. CHP 4821 Bel Pre Road Rockville, MD 20853
OVERHOFF TECHNOLOG':t CORPORaTION DOCKET NUMBER PR 3 I PROPOSED RULE_
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USNiC "92 MAR -2 A 8 :33 1160 U.S. ROUTE 50 MILFORD, OHIO 45150-9705 vFF!CE: Gr StCRl TAH V OOCKfi iNli !, SFilVICf.
(513) 248-2400 The Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 Attn : Docketing and Services Branch Re; Proposed Rules, as Published BRANCH February 18, 1992 in the Federal Register, Vol 56 No 249, December 27, 1991 Gentlemen :
We have reviewed the above cited document with some trepidation and astonishment.
Our reaction to the "Summary" is to express our opinion that a change in NRC regulations is unneccessary, and that such action (by the NRC) is a waste of the taxpayers '
money.
Especially these days.
Our reasons for this statement are quite simple.
I don't believe for a moment that any reputable, serious and consciencious manufacturer or service organization involved in "measuring,
gauging or controlling devices" would ever consider placing his (her) equipment in the hands of a customer (of while in his own premises) without proper safeguards, including instructions, documentation, etc.
Certainly, we never intended such.
In this day and age of product liability,
irresponsible litigation, and the general public ' s poor understanding and opinion of things nuclear, it would be stupid and short sighted on anyone ' s part not to prudently ensure the safety and cooperation of all individuals involved in a transfer of goods,
services, know how, etc.
Therefore, we consider your rpoposal overkill and a simple waste of taxpaers ' money.
On page 67014, "Paperwork Reduction Act " you claim that the proposed rule would only impose a burden of "20 minutes of response", at a cost of
$10 per device (page 67013).
In other words,
private industry ' s time is worth $3 0 per hour, but your own agency ' s fee structure is such that you wish to charge $150 per hour for your services { f(l?Alt't',I MWO:blw Yo;J[TJ/
M. W. Overho~V Ph. D.
APR 15 1991 Pres i dent cc :
The Honorable Willis Gradison Ackn wledged by card.......................
U.S. NUCLEAR REGULATORY COMM!-
ION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETAR¥ OF THE COMMISSION Document Statistics Postmark Date :i., :2 " f ~
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DOCKEi NUMBER Pl 3)
PROPOSED RULE J ~ I' )
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Bethlehem Steel Corporation C CKCED USNRC BETHLEHEM, PA 18016
'92 FEB -7 A10 :11 OFT/CE Or SECRETARY OOCKi:T 1NG t. SE flV IC!.
January 31, 1992 BRANCH Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention:
Docketing and Service Branch Gentlemen:
This pertains to the proposed rule published in the December 27, 1991 Federal Register, Volume 56, No. 249, Pages 67011 through 67017, "Requirements for the Possession of Industrial Devices Containing Byproduct Material", 10 CFR Parts 31 and 32.
Bethlehem Steel Corporation strongly commends the Commission in addressing the problem of unaccountability of generally licensed gauging devices that could have a severe impact on the health and safety of our employees and the potential for serious contamination of our facilities if melted as part of a scrap shipment.
While detection systems have been installed to monitor our incoming scrap, no detection system can be 100 percent efficient.
The proposed rule could also help strengthen the impression of the general public that radioactive material is being adequately regulated.
This could have a beneficial effect on both users and regulators.
The following specific comments are offered for your consideration:
- 1.
- 2.
The philosophy behind deleting the references to generally licensed devices distributed by manufacturers located in agreement states in 31.5(b) is not understood. If the proposed wording is adopted, it would mean that companies in states in which the NRC has jurisdiction could only obtain generally licensed devices distributed by manufacturers who are also under NRC jurisdiction. This would prevent some of our facilities from buying generally licensed devices from Texas Nuclear, Kay Ray, Data Measurement Corporation, just to name a few.
The proposed wording appears to restrain free trade and places manufacturers in agreement states at a definite economic disadvantage, while preventing general licensees in non-agreement states from obtaining possible state-of-the-art or one-of-a-kind devices. It is suggested that Section 31.5(b) not be changed from its present wording.
It is suggested that the NRC wording and that of the states be identical. If generally licensed devices are essentially "inherently safe", there should be no reason for a state to have more stringent regulation than that proposed by the NRC.
Multiple requirements, differing from state to state would destroy the concept of reciprocity and increase the cost of manufacturing and distributing devices with no increase in actual safety.
APR 15 1992 -----.
Acknowledged by card """*"'""'"'"'" """""'
J.:.
J. -:*.: *,. iicGULArORY COMMISSION
,;(.'~~Kt: fl NG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ~ / 3 f q ~
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- 3.
Using the data provided in the supplementary information section, if 10 percent of the general licensees failed to make the required responses and could not be easily contacted by phone, there could be as many as 700 licensees that would have to be personally contacted per NRC region.
This would significantly increase NRC staffing, requiring from two to four additional persons per region.
There is no mention of how the NRC proposes to pay for this increased staff. It is strongly recommended that any expenditures for added staffing be paid from assessments made on Part 31 and Part 32 licensees and not be hidden in the general fees levied against Parts 30, 40 or 70 licensees.
Please give these comments serious consideration in finalizing and implementing the proposed changes to Part 31.
ALaMastra:kjk Sincerely, f~ H-1 t4._4--
Edwin H. Toothman Director, Occupational Health Health and Safety Services
~~ I
'-.+.lohnson
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S.C. Johnson & Son, Inc.
1525 Howe Street Racine, WI 53403-5011 Phone: (414) 631-2000 January 9, 1992 Secretary Docketing and Service Branch U.S. Nuclear Regulatory Commission Washington, DC 20555 LJCK[1Er!
LJ'.:)NHC
°92 JAN 14 P 2 : 11 0FF!Cf.: or SECRFlARY OOCK[TiNG t, SEiiVICf.
8RANCl-i (j)
RE: RIN 3150-AD34 "Requirements for the Possession of Industrial Devices Containing Byproduct Materials", dated December 27, 1991 at 56 FR 67011-17.
Gentlemen:
The U. s. Manufacturing Division of s. c. Johnson and Son, Inc.
(Johnson Wax) wishes to* comment on NRC's proposed RIN 3150-AD34:
"Requirements for the Possession of Industrial Devices Contain-ing Byproduct Materials" which appeared in the Federal Register on December 27, 1991 (56 FR 67011-17).
Comments
- 1.
10 CFR 31. 5 ( c) ( 11) (iii)
We suggest NRC revise its proposed 10 CFR 31.5(c) (11) (iii) to allow the listing of more than one "responsible" individual:
- 1.
The individual responsible for the device and
- 2.
The individual responsible for ensuring compliance with the appropriate regulations and requirements.
The reason for this change is to allow a device user to assign one individual to operate the device and other to be responsible for its maintenance.
As written, the Commission has assumed one individual will be responsible for both operating the device and its maintenance.
- 2.
We suggest NRC revised its proposed 10 CFR 31.5(c) (11) (iv) to allow the listing of more than one "address at which ' the device is located or used".
b~
Acknowl ed FEB O $ 1a 8dg by card **snn:e*:s;ne:13n:,*Mmq-
U.$. r,fUCLEAf'i REGUL.AT 0RY COMMiSSION OOGl<ET!NG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISOON Document Statistics Postmark Dalt --J.-1-.1.-:...-&.,....1..;.P..~--
Coples Add1 Copiu
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Secretary Page 2 January 9, 1992 When NRC drafted 10 CFR 31.5(c) (11) (ii), the commission assumed that more than one of the same device may be possessed.
By the wording of 10 CFR 31.5(c) (11) (iv), it would appear the NRC has assumed (where multiple devices are indicated) that all of the devices would be used at the same location.
While NRC's first assumption is reasonable, its second is not.
There is nothing that would prohibit the location of devices in more than one location, especially if independently used.
- Thus, we suggest that 10 CFR 31.5(c) (11) (iv) be redrafted to suggest that more than one location may be listed.
[We would also suggest that the NRC discuss reporting under this part where a device may be used in more than one location (e.g.,
a portable gas chromatograph with a sealed source for electron capture capability).]
Johnson Wax wishes to thank to comment on this proposal.
assist the Commission in the rule.
NRC f or providing this opportunity We hope that these comments will development of a cost-effective If you wish to discuss these comments further, please feel free to contact me (414/631-3570).
Sincerely yours,
~
f.~frooto Consulting Engineer U.S. Safety and Environmental Affairs GIM/goa OOOOG c:
G. A. Krieger T. T. Stocksdale
NUCLEAR REGULATORY COMMISSION 10 CFR Parts 31 and 32 RIN 3150 - A034 Requirements for the Possession of Industrial Devices Containing Byproduct Material AGENCY:
Nuclear Regulatory Commission.
ACTION:
Proposed rule.
ooc.:KUED ustmc
SUMMARY
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the safe use of byproduct material in certain measuring, gauging, or controlling devices.
The proposed changes, among other things, would require general licensees who possess these devices to provide the NRC information about the identification of devices and the people responsible for the devices. Further, specific licensees who are distributors of generally licensed devices under 10 CFR 31.5 would be required to use a uniform format when submitting the quarterly transfer reports to NRC.
The proposed rule is intended to ensure that general licensees are aware of and understand the requirements for the possession of devices containing byproduct material.
This awareness will better assure that general 1
licensees will comply with the
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I requirements for proper handling and disposal of generally licensed devices and presumably reduce the potential for incidents that could result in unnecessary radiation exposure to the public.
DATE:
The comment period expires 75 days after publication.
Comments received after this date will be considered if it is practicable to do so, but the NRC is able to ensure consideration only for convnents received on or before this date.
ADDRESSES:
Mail written comments to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, ~ttention: Docketing and Service Branch.
Deliver comments to One White Flint North, 11555 Rockville Pike, Rockville, MD, between 7:30 am and 4:15 pm on weekdays.
Copies of the draft regulatory analysis, as well as copies of the comments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW. {Lower Level),
Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3795.
2
SUPPLEMENTARY INFORMATION:
Background
On February 12, 1959 (24 FR 1089}, the Atomic Energy Commission amended its regulations to provide a general license for the use of byproduct material contained in certain luminous, measuring, gauging, and controlling devices.
Under the current requirements for possession of a general license, certain persons may receive and use a device containing byproduct material if the device has been manufactured and distributed in accordance with the specifications contained in a *specific license issued by the NRC or by an Agreement State. A specific license is issued based upon a determination by a regulatory authority that the safety features of the device and the instructions for safe operation are adequate and meet regulatory requirements.
The general licensee is required to comply with t~e safety instructions contained in or referenced on the label of the device and to have the testing or servicing of the device performed by an individual authorized to manufacture, install, or service these devices. A generally licensed device is a "black box," that is, the radioactive material is contained in a sealed source usually within a shielded device.
The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus, the general license policy is a mechanism to simplify the license process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.
3
Discussion There are about 600,000 devices that contain byproduct material in use by about 35,000 licensees under the ColTlllission's general license regulatory program.
General licensees have not been contacted by NRC on a regular basis because of the relatively small radiation risk posed by generally licensed devices. These devices have survived fires and explosions on many occasions without a total loss of shielding. They have been damaged by molten steel, and hit by construction vehicles with only minor losses in radiation shielding while maintaining the integrity of the source capsule.
Nonetheless, there have been a number of occurrences where devices containing radioactive material have not been properly handled or disposed of and resulted in radiation exposure of the public. Although no significant public health and safety hazards resulted from these incidents, if proper handling and disposal procedures had been followed, these avoidable exposures would not have occurred.
For example, one or more cesium-type gauges were mixed in with some scrap metal that was-melted down to form steel and the entire batch of steel was contaminated.
In another instance, a static eliminator bar with 22.5 millicuries of americium-241 was sent to a sanitary landfill over which the NRC has no jurisdiction. There have been other types of incidents involving NRC generally licensed devices including damaged devices, leaking or contaminated sources, and equipment malfunctions.
However, loss of accountability, as occurred above, remains the most frequent incident and the predominant concern.
Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards (NMSS) conducted a radiological risk assessment addressing 4
storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill.
NMSS included in the risk assessment an incident at a steel company in 1983 (discussed in NUREG-1188, "The Auburn Steel Company Radioactive Contamination Incident") that probably represents a worst-case scenario for generally licensed gauging devices. Although individual doses were low and within prescribed limits for exposure of members of the public, they nevertheless represent unnecessary additional public exposure that could have been avoided.
In addition, the cleanup costs were in excess of four million dollars with additional costs incurred for the staff efforts of regulatory agencies.
In consideration of both the risk assessment and incidents like those noted above, the NRC conducted a three-year sampling (1984 thru 1986) of general licensees (taken from the vendors' quarterly reports) to determine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary.
The sampling was conducted both by telephone calls and site visits. The sampling revealed several areas of concern regarding the use of radioactive material under the general license provisions.
On the basis of the sampling, the NRC concluded that there is:
(1) a lack of awareness of appropriate regulations on the part of the user (general licensee) and (2) inadequate handling and accounting for these generally licensed devices.
The NRC further concluded that these two problems could be remedied by more frequent and timely contact between the general licensee and the NRC.
This conclusion by the NRC provides the basis for the regulatory changes proposed in this action.
5
An estimated 70,000 Agreement State licensees use the types of sources and devices covered by the amendments being proposed today for the NRC's general licensees. Consequently, the States will play an important role in achieving improved regulatory oversight on a national basis.
Many of the States already have accountability programs in place.
The Agreement States participated in the development of this rule and indicated agreement with the concept of the proposed rule. Specific comments from the Agreement States were adopted except for suggestions that the NRC charge general licensees fees and that there is no need for a standard format for submitting information.
The fee issue will be addressed separately. The proposed rule provides flexibility in the use of the standard format.
The Co11111ission is considering making the amendments a matter of compatibility for the States. The NRC staff has suggested that the amendments be categorized as Division 2 level of compatibility. This level of compatibility requires that States address provisions in NRC regulations relating to basic principles of.radiation safety and regulatory functions without necessarily using identical language.
States may also adopt requirements more restrictive than NRC rules under this level of compatibility. The Co11111ission would appreciate comments~ on this suggestion.
An estimated 35,000 persons use certain measuring, gauging, or controlling devices under the NRC's general license.
NRC regulations that affect these general licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.4, 31.5, and 31.6.
Under 10 CFR 31;2, nTerms and Conditions,n all general licensees are subject to certain provisions of P~rt 30 and also Parts 19, 20, and 21.
The proposed revision to § 31.2 would also 6
subject all general licensees to the requirements of 10 CFR 30.9, "Completeness and Accuracy of Information," which imposes certain requirements regarding the completeness and accuracy of the information submitted to the I
NRC by licensees not now imposed upon general licensees.
Section 31.4 of 10 CFR Part 31, "Information Collection Requirements:
0MB approval,u lists the various sections of Part 31 that contain approved information collection requirements.
Paragraph {b) of§ 31.4 is being amended to add § 31.6 to the approved listing.
Section 31.5, "Certain measuring, gauging or controlling devices,"
provides for a general licensee to acquire, receive, possess, use, or transfer byproduct materials. It also specifies the responsibilities of general licensees regarding the use of byproduct materials.
Under the proposed revisions a new paragraph {c}{ll} would be added to require the general licensee to provide specific information to the NRC upon request. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; name, title, and telephone number of the person responsible for controlling the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph {c} of§ 31.5 have been met.
In addition, a proposed revision to paragraph {b} of§ 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement States.
The registrati-0n and verification system contained in *the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources.
If older sources 7
are transferred, they would be subject to the same requirements as newer sources and the registration system is intended to capture them.
General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing provisions of 10 CFR 31.S(c) (8) and (9).
In both cases, licensees must notify the NRC of the transfers. If the specific licensee is a 10 CFR Part 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply to any subseque~t transfers. The current NRC data base, although limited, includes identification of general licensees who acquired gauges as early as 1959.
The NRC staff plans to contact these licensees and any new general licensee as part of the enhanced oversight effort.
At present, 10 CFR 31.6, *General license to install devices generally licensed in § 31.5,* provides a general license to certain specific licensees from Agreement States to install or service devices used under§ 31.5.
The current regulation, 10 CFR 31.6, is not clear with respect to time restrictions.
10 CFR 150.20(b}(3}, imposes a ISO-day-per-calendar-year limitation on the activities of Agreement State Ltcensees in non-Agreement States. The proposed amendments to § 31.6 would remove this restriction for
§ 3 I. 5 l i censees. This change will be convenient to the NRC, Agreement States, and manufacturers because it will r_educe and simplify paper work without in~reasing the risk to public health and safety.
The proposed § 31.6 (a} would require the general licensee holding a specific license from an Agreement State to report to the NRC all p~rsons receiving a device from the licensee, as specified in the accompanying proposed revision to § 32.52.
Proposed § 31.6 (d) would require the licensee to supply each of the 8
recipients of a generally licensed device a copy of the general license contained in § 31.5.
Proposed § 31.6 {e) would require that written instruc-tions and precautions be provided to persons servicing a generally licensed device.
Proposed § 31.6 {f) would also require a person performing routine installation/servicing/relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to the start of the activities. This notification would allow for a level of periodic inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded radiation source. It is not intended that the
(
prior notification requirement apply in cases where a radiological hazard due to an accident or a malfunction of the device exists.
To be consistent with the proposed modifications, the section heading would be amended to read "General license to distribute, install, and service devices generally licensed in § 31.5.R 10 CFR 32.51a, "Same:
Conditions of licenses," presently imposes conditions on applicants for a specific license to manufacture or initially transfer generally licensed devices to general licensees. The addition of proposed paragraph {c) to § 32.51a would requir~ such specific licensees to provide recipient users of generally licensed devices with written instructions and precautions to ensure that the devices are used safely.
In addition, these specific licensees would be required to provide those users with information regarding testing requirements, transfer and reporting requirements, and disposal options for.the devices being transferred.
10 CFR 32.52, "Material transfer reports and records,R currently requires specific licensees authorized to distribute devices to general licensees to 9
file transfer reports with the NRC on a quarterly basis. The revised regulation would prescribe the format to be used when submitting transfer reports to the NRC.
The proposed format would provide more detailed and complete information about the general licensee to whom the-device is transferred.
The format is presented in proposed Subpart E, § 32.310.
Licensees who do not use the prescribed format would be permitted to provide all of the information required by the format on. a clear and legible record.
In addition, specific licensees would be required to identify a person responsible for meeting the requirements associated with the possession of the generally licensed device rather than simply identifying a point of contact at the general licensee's location.
After receipt of the quarterly transfer reports from the specific licensee under§ 32.52, the NRC would send letters to the general licensees who received the devices during the preceding reporting period requesting them to verify in writing that they had purchased the devices containing byproduct material and that they understand the requirements of the general license.
The general licensee under proposed § 31.S{c){ll){ii) would be required to respond to the NRC by letter and to verify safety-related information about the device and its location. Thereafter, notices would be sent periodically to the general licensees requesting that they verify that they still have the device, verify the safety-related information, and remind them of their regulatory respqnsibilities in ustng the device.
The frequency of these letters may range from 1 to 3 years.
Any failure to respond or any reports of lost devices would initiate NRC follow-up action. This contact between the NRC and the general licensee would allow the NRC to validate and update the 10
information currently contained in the data base that the NRC maintains for its general licensees.
Although these proposed requirements would impose additional costs on licensees, the Convnission has estimated these to be nominal (on the order of
$10 per device). Accordingly, the Commission believes that the increased compliance by general licensees and confidence in the appropriateness of the general license program potentially afforded by these new requirements outweigh this cost. Nonetheless, the Co11111ission particularly requests corrments on this matter.
At the time of the final rulemaking on this matter, the Commission intends to provide for an interim enforcement policy to $Upplement the current Enforcement Policy in 10 CFR Part 2, Appendix C, to address violations arising from the proposed regulations.
The interim policy would remain in effect for one cycle of the notice and response program, approximately three years.
. Under the existing NRC Enforcement Policy, significant violations such as those involving lost sources may result in escalated action including civil penalties. The interim policy would provide that in the initial phase of the implementation of a.notice and response program, enforcement action would not nonnally be taken for violations identified by a licensee in submitting infonnation pursuant to the proposed regulation provided appropriate corrective action is initiated. This change from the Convnis~ion's normal enforcement policy in 10 CFR Part 2, Appendix C, is to remove any disincentive to identify deficiencies caused by a concern of potential enforcement action.
This action would be taken to encourage general licensees to search their facilities to assure sources are located, to determine if applicable requirements have been met,, and to develop appropriate corrective action when 11
deficiencies are found.
However, enforcement action will be considered for violations involving the failure to provide the information requested or take appropriate corrective actions or willful violations including the submittal of false information. Sanctions in those situations may include civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license.
Environmental Impact:
Categorical Exclusion The NRC has determined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22(c}(3}(iii}.
Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Redu_ct ion Act Statement The proposed rule amends the information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.}. This proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.
The public reporting burden for this collection of information is estimated to average about 20 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this 12
burden, to the Information and Records Management Branch (MNBB-7714), U.S.
Nuclear Regulatory Commission, Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-3019, (3150-0016 and 3150-0001), Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis The NRC has prepared a draft regulatory analysis of this proposed regulation.
The analysis examines the cost and benefits of the alternatives considered by the NRC.
The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the draft analysis may be obtained from Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: 301-492-3795.
Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact on a substantial number of small entities. The NRC has adopted size standards that classify a small entity as one whose gross annual receipts do not exceed $3.5 million over a 3-year period.
The proposed rule affects about 35,000 persons using products under this general license, many of whom would be classified as a small entity. However, the NRC believes that the economic impact of the proposed requirements on any general licensee would 13
be negligible. The proposed rule is being issued to better ensure that the general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.
Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to these proposed rules and therefore a backfit analysis is not required because these proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(l).
List of Subjects in 10 CFR Parts 31 and 32 10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment.
10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment.
14
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, 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 31 and 32.
PART 31 -
GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
- 1.
The authority citation for Part 31 is revised to read as follows:
Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 {42 U.S.C. 5841, 5842).
Section 31.~ also issued under sec. 274, 73 Stat 688 {42 U.S.C. 2021).
For the purposes of sec. 2~3, 68 Stat. 958, as amended (42 U.S.C. 2273);
§§31.5 (c)(l)-(3) and (5)-(9), 31.6, 31.8(c), 31.lO(b), and 31.ll(b), (c),
and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.
220l(b); and §§31.5 (c)(4), (5), (8), and (11), 31.6 (d)-(f), and 31.ll(b) and (e) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C.
2201(0)).
- 2.
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 provision of§§ 30.9, 30.14(d), 30.34(a) to (e), 30.41, 30.51 to 30.63, and Parts 19, 15
20, and 21 of this chapter1 unless indicated otherwise in the language of the general license.
- 3.
In § 31.4 paragraph (b) is revised to read as follows:
§ 31.4 Information collection requirements:
0MB approval.
(b}
The approved information collection requirements contained in this part appear in §§ 31.5, 31.6, 31.8, and 31.11.
- 4.
In § 31.5, paragraph (b) is revised and paragraph (c)(ll) is added to read as follows:
§ 31.5 Certain measuring, gauging, or controlling devices. 2 (b)
The general license in paragraph (a) of this section applies only to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to § 32.51 of this chapter or in accordance with the specifications contained in the general license of
§ 31.6.
(c) 1Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.
2Persons 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.
16
(11) Shall respond within 30 calendar days of receipt of a request from the Nuclear Regulatory Conrnission to verify the following information and any other such information as may be requested by the Conunission as it relates to the general license. Further, the general licensee shall notify the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Conrntssion, Washington D.C. 20555 within 30 calendar days if any of the requested information should change.
(i)
Name and complete address of the general licensee.
(ii) Identification of specific information about the device, such as:
the manufacturer, model number, the number of devices, type of isotope, and who has performed what service on the device since the last report concerning the device was submitted to the NRC.
(iii) Name,.title, and telephone number of the person who is responsible for the device and for ensuring compliance with the appropriate regulations and requirements.
(iv) Address at which the device is located or used.
(v)
Whether the requirements of§ 31.S(c)(l) through (c)(l0) have been met.
- 5.
Section 31.6 is amended by revising the section heading and the introductory paragraph and by adding paragraphs (a), {d), (e), and (f) to read as follows:
§ 31.6 General license to distribute, install, and service devices generally licensed in § 31.5.
17
Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices described in § 31.5 within the Agreement State is hereby granted a general license to distribute, install, or service the devices in any non-Agreement State for an unlimited period of time and a general license to distribute, install, or service the devices in offshore waters,, as defined in § 150.3(f),
provided that:
(a)
The Agreement State licensee files the appropriate transfer reports as required by paragraphs (a) and (b) of§ 32.52.
{d)
The person shall furnish a copy of the general license contained in
§ 31.5 of this chapter to each person who is responsible for the byproduct material and for ensuring compliance with the appropriate regulations and requirements.
(e)
The person shall provide the individual responsible for service of the device with written instructions and precautions necessary to ensure its safe installation, operation, and service. These instructions shall include leak-testing requirements, transfer and reporting requirements, disposal options, including possible costs and reporting requirements for lost or damaged devices.
(f) The person performing routine service/installation or relocation of devices shall notify the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter at least 3 working days prior to engaging in such activities in Non-Agreement States. The notification shall include the date and location of the activity that will be performed.
Prior notification does 18
not apply in cases where a radiological hazard due to an accident or malfunction of the device exists.
PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 6.
The authority citation_ for Part 32 continues to read as follows:
9 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).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
§§ 32.13, 32.15 (a), (c), and (d), 32.19, 32.25 (a) and (b), 32.29 (a) and (b), 32.54, 32.55 (a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201 (b)); and
§§ 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(0)).
- 7.
Section 32.51a is amended by adding paragraph (c) to read as follows:
§ 32.51a Same:
Conditions of licenses.
(c)
Furnish the individuals identified under§ 3i.5(c)(ll) or §31.6(d) with written instructions and precautions necessary to ensure safe installation, operation, and service of the device. These instructions must include the leak-testing requirements, transfer and reporting requirements, 19
disposal options including possible costs, and reporting requirements for lost or damaged devices.
- 8. Section 32.52 is revised to read as follows:
§ 32.52 Same:
Material transfer reports and records.
Each person licensed under§ 32.51 or§ 31.6 to initially transfer devices to generally licensed persons shall:
(a) Report quarterly to the Director of the Office of Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, and send a copy of the report to the appropriate NRC regional office listed in Appendix D of Part 20 of this chapter all transfers of such devices to persons for use under the general license in § 31.5 of this chapter.
The report must be provided either in the format presented in Subpart E,
§ 32.310, "Transfer Report Format," or on~ clear and legible record as Jong as all of the data required by the format is included. If one or more inter-mediate persons temporarily possesses the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediary as in Subpart E, § 32.310, and clearly designate that person as an intermediary. If no transfers have been made to persons generally licensed under§ 31.~ during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.
(b) Report quarterly to the responsible Agreement State agency all transfers of such devices to persons for use under a general license in an Agreement State's regulations that are equivalent to§ 31.5. The report must 20
be provi,ded either in the format in Subpart E, § 32.310, "Transfer Report Format," or on a clear and legible record as long as all of the data required by the format is included.
If one or more intermediate persons temporarily possesses the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediary as in Subpart E, § 32.310, and clearly designate that person as an intermediary.
If no transfers have been made to persons generally licensed under§ 31.5 during the reporting period, the report must so indicate.
The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.
{c)
Keep records of all transfers of such devices for each general licensee and in compliance with the above reporting requirements of§ 32.52.
Records required by this section must be maintained for a period of 5 years from the date of-the recorded event.
- 9.
Subpart E, Section 32.310 is added to 10 CFR Part 32 to read as follows:
Subpart E - Report of Transfer of Byproduct Materials
§ 32.310 Transfer Report Format.
This section contains the format required by § 32.52.
21
Subpart E-Report of Transfer of Byproduct Materials S~ctio_n 32.310 - Transfer Report Format NAME OF VENDOR AND LICENSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE INFORMATION COMPANY NAME. STREET, CITY, DEPARTMENT STATE. ZIP CODE PERSON RESPONSIBLE FOR CONTROL OF THE DEVICE NAME AND TITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY ANO UNITS NUMBER NUMBER
~
Subject:
Requirements for the Possession of Industrial Devices Containing Byproduct Material (RIN 3150-AD34).
Dated at Rockville, Maryland this p -dday of L/!.,,.~
1991.
For the Nuclear Regulatory Convnission.
or for Operations 23