ML20141N582
| ML20141N582 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/1986 |
| From: | Norry P NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | |
| References | |
| OMB-3150-0124, OMB-3150-124, NUDOCS 8603170192 | |
| Download: ML20141N582 (15) | |
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m. _" _. _. s Request for 01W8 Review ~yj',O p, (LLs_
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i t"" W 3 *8 33 Road enstructens before completing form. Do not use the same $F 83 Send three copies of this form, the material to tm reviewed. and for n roguest teeth an Esecutive Order 12291 review an<1 approvat under paperwork-three copies of the supporting statemerit. to:
the Paperwork Reduction Act.
Answer all questens in Part i If this request is for review under E.O.
Offece of Information and Reguietory Af fairs 12291 cornpiete Part li and s'gn the regulatory certificat.on if this Office of Management and Budget reeuest is for approval under the Paperwork Reduction Act and $ Cf R Attention. Dochet Labrary Room 3201 1320. ship Part it, complete Part fit and sign the paperwork certification, Washington DC 20503 PART l.-Complete This Part for All Requests,
- i. ve.,imenv ency.nd eu,e.u. otfice....iine,equni
- s. As.n., c.ie L'.S. Nuclear Regulatory Conmiission 3 1 5 0
- 3. nem. oi pe.on.wo un 6nt.n.eu m,ni. s,es.,o.ns ia.$,eowest t w..ume.
Steven L. Ba99ett
< 301 3 427-9005
- 4. istie of enformaten coelett.on or rutam.6 ng Survey of Users of Devices Under General License
- 5. Legal authority for enformaten conect.on or rule (c.fe umted Ststes Cotte, /'ubt.c (an. or i necurne OrderJ 42 2201(c) usc G Anxted pubeucriua,s eruraeri s O rede,,,,cee m o,e<n e yees
! O ind.vido.i,nousenoids a Q r..ms 6 p) t4on s o a asiiwi-r i
2 O st.e. o,i.e iso e,n,nenii 4 c; nosmei.es e, oinc en, p<o' t 7 r. sm.iiis,s.aenese,e,s n.<,iens PART ll.-Complete This Paet Only if the Request is for OMS Review Undte Esecutive Order 12291 l
- 7. Pegulation identd et Nurr+et (RiN)
'"~ _ _ _ _ or. f4one ass gned O
- 5. Type of subm.ssen (< en a ore in eesit category)
Type et se,tei e.gvested i
OssefNth Stage of doeAppeneef I C $tandard I O u.,o, i O e,oposed e,e,.ei 2 O rend.n, 2 O N m tot
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3 0 rin.i e,inte.,i ec.i. innui pree p,r, 4 0 si.ia,o,,o,y w ide.d'me M. cf R section d'fected CrR
- 10. Does thee restutet.on conta.n report.no or rnorateeping requiremer'ts that #equae OMB approvat unde # the Pepee.oeh peducf.oei Att end s CrR 1320' O Yn ONo
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Coettflesteen fee Regulatory submissione In subm tt.ne theo request toe 0Mri veven. tbe auf moeired regu atory tentset e~t the rncam ott.oac c ertd, that the requaemeati e;# t 0 12291 an.t eny es pi. cabs, r
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PART lit.-Complete This Part Only if the Roguest is for Approval of O Collection of latermetion Under the Paperwerk Reduction Act and 5 CFR 1320.
- n. Abstrut-cexnbenuds.umandenecteoputw.cin so.orosorien " Radioactive materials radiation safety" - Devices s
containing radioactive byproduct material are used in a nunber of: industrial applications, under a general license established by the Consnission, for producting light, analytical measurements, or elimination of static. NRC will conduct a survey of a sample of users to acquire data for a study of the effectiveness of the general license in protecting public health and safety.
- 14. Type of mfortnaten collecten (checa only one) in0ermotion conectlene not contaheed he rueee 1 $ Regulaf subm ss oa 2 O t=ergeacy submas.ca rcert<r carea arrache4) s 0er seien comece e e ceneau.ed n.,us.
3 O t..stes requistion (no cha,,,e p, opened; 6 r.nai o,.nte,.m fmai..tncut pnar NeRu
- 7. tree, deio of e.pected er actuai r eoersi 4 O Not.co of proposed rutomammg(NPRM)
A O neevia, subm.is.n nes sie< pubi<anen et teus ita e et ruiemaa.ns 5 O rmai. Neau.as or ous'y pubhshed e O tmergency submri a rcerf,tarat.on attached) 0"aa'a. der. rear)'
- 15. Type of revew requested (checa only one) 4 O nemstatement of a pree.use appro.ed coeiect.en for -h<a appeo.se 1 O New collection r
- "'"'d 2 O pe. on of a current's acero ed coeiectea 39 tatenssonof theesperatoondateof acurrentlyapprovedconectaa s O taistme co'ieci.on m us -ahaut sa owe cenero number
=,thout any c haage in tne substance or in the enethod of conect on
- 22. Purpose of 6n ormation costecten(chece as many as appfy)
- 16. Agency report form numtwr(s)(enclude standard /optenal form nu.s6er(s))
e N/A I O App +< tentoebeaetits 2 O Progeam aiveten
- 17. Annual reporpng or diutosure twrden 3
g,,,p p,,,,,,,,,,,,g, 1 Nurnber of respondents.
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Reguistory or compt.ance 2 N smbee of resprntes pee respondent, s @ Program planning or management 3 Total annust t sponses (sne i tomes hoe 2) 6 O ne,earcs O.58 7 O Audt 4 Hours per response s Tntsi hours it.no 3 t>mes hee el 200
- 18. Annual tocoro6*epmg buroen
- 23. F requency of recorcheeperig or reportmg(checa as that appry)
! Number of recorcheepers,
1 O pecordaeepes
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2 Annual houri pc recerasupc.
Neport8nt 3 Total recordteep.ng hours (l<ne I f.mes Ane 2) 2 O onoccas.on 4 Recordbeepeeg toteation pe'ed y* *
3 0 wee 6 y 13 Total annual burden 4 O monthey 280 l peounted(kne 17 9 plus kne 18-3) s O Quartetty 2 In cureeat oMe inantory 6 O some annuent b
3 o+fference(kne iless I.ne t) 1 O Annuelty Espoonet6en eterNerence 8 0 9,enneany 4 Pts grem thenge 9 $ Othef(duct 6e).
s Adsst,nent
- 20. Current (mest receat) oMB ccatroi nuentee or comment numtwe
- 24. Respondents' obbeation to comp #y(chec4 the stoorgestoedgretsart that apphes) 3150-0124 I O veuntary
- 21. neoveited op.<atea date 2 n peous,rd io obt,.n o,,,ta n a benet,i 12/31/87 3 pj uandato,,
2 S. Are the resptenderts pr. mare *y educatsor.al agencies or 6nstitutens or 4 the primary purpose of the copecten related to Fedetal education proseamse
- 24. Does the seencf use sampeg to setect respondents or does the agency secommend or preuribe the use of sarnphes ce statrster.at analys
. O ves O No by responoents EMegulatory author.ty for thein'ormatinn cosiection cfR
- ce fH
,or,othev(specsty)..
Paperwerk Certifkehen in submitteg thrs eequ st for OVR approval, the agency head, the sen.or official <+ an authortred representative, certif.es that the requwements of s Cf R 1320, the e
Privaey Act. stat,st cat standves or d.rer.trves, and any othet opphcabte informaten ont<, owe < tives have been comphed with Mte 5.gnature of prog,em ett. oat r
he d t +. ear,r c4,os8tw an authorised tepresentat,ve Oate
$gratu eof ageneIcle 'G.Norry s Director Patr Office of Administration
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J7W (s r,g.n, geni 4 o. 4g3 776
SUPPORTING STATEMENT FOR SURVEY OF USERS OF DEVICES UNDER GENERAL LICENSES IN 10 CFR 31.3, 31.5, 31.7, 31.8, 40.22, 40.25, and 70.19 Sumr'ary of Study As a result of the findings from the special study on Section 31.5 general licenses, the NRC plans to telephone and visit a sampling of persons that use devices containing byproduct material. These devices are used for producing light, analytical measurements, or elimination of static. Approximately 150,00-250,000 devices are used under these general licenses. Traditionally, NRC (formerly AEC) has little contact with generally licensed gange users.
In the study, regular, part-time and co-op employees of NRC will ask device users to account for devices that they have received and to answer short ouestions about installation and maintenance of the devices.
No written responses will be required of device users. Thesurveyquestionnaire(sampleattached)will be completed by the interviewer. The acquired data will be considered, along With data from other sources, to determine if there is a regulatory problem with the general licenses for devices other than gauges.
NRC planned to carry out the survey during FY 1985 using sumer and part-time employee. However, the sumer staffing was not assigned as anticipated, so the survey could rot be completed during that time. NRC now expects to schedule the conduct of the survey by regular and part-time employees on a as-available basis along with regular work assignments. CO-OP cmployees have also been assigned to augument the data collection part of the survey.
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Justification Need for and Practical Utility of Information Collected Under a special study initiated during the summer of 1984, the NRC contacted a I:-
sampling of persons that use gauges containing byproduct ~ material. These persons were licensed un6er the Section 31.5 general license. The contacts
. were made under OM8 approval Number 3150-0124. This study was to acquire data and answer the-questions of whether NRC has a problem with respect to gauge users under the general Itcense.
i From this study we found that in fact the general licensees were not,'in all cases, adhering to the rules and regulations of Section 31.5.
Futhermore, some gauges were found to be unaccounted for and a final disposition cculd not be determined by the user. This lack of adherence to the regulations has also-(
prompted potential public health and safety concerns with the other general
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' licenses in 10 CFR. These other users possess between 150,000-250,000 devices (other than gauges) under the general licenses of 10 CFR 31.3, 31.5, 31.7, l31.8,'40.22, 40.25, and 70.19.
We are requesting permission to survey by telephone and site visits a sample set from the remainder of the general licenses.
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l These contacts will be made by NRC employees. The employees will not be l;
authorized to perform NRC inspections but will merely gather information.
I We eFpect to have acquired the major portion of the data by December 1986. At f-that time we will develop tentative findings to help answer the questions of whether NRC also has a problem with the other general licenses and if there is l'
a problem,'what remedial action should be taken.
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The results of this survey will be used with results of the Sumer 1984 study to support any corrective action that may be deemed necessary.
The following section provides a brief summary on each licensee effected by the
- proposed data collection. Please keep in mind that under a general license a person may obtain and use a device without obtaining a specific license from the NRC. This is, the person does not submit an application for a license authorizing use of the radioactive material.
V Section 10 CFR 31.3 of the NRC's regulations provides a general license for-the use of static elimination devices and ion generating tubes.
An estimated 60,000 devices are distributed annually to persons throughout the USA. The devices may be used to eliminate static from records or films. The device may cost between 6 and 30 dollars.
Devices used under the Section 31.3 general license must be manufactured and distributed under a specific license issued only by the NRC.
The general license in Section 31.3 has been part of the NRC's (formerly the AEC's) regulation for over 29 years.
.Section 10 CFR 31.5 of the NRC's regulations provides a general license for the use of certain devices containing radioactive material.
An estimated 40,000 devices other than gauges (i.e., static elimination, exit markers, analytical equipment) is used under the license. The devices may be i
used in a wide range and sophistication of uses and cost. A simple device may be used to eliminate static in air streams while a more complex device may be
.used to determine the content of materials by X-Ray flourescence techniques. A simple device may cost 10 dollars. More complex devices may cost several thousand dollars.
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Devices used under the general license in Section 31.5 must be manufactured and distributed under a specific license issued by the NRC or by an Agreement State. The device must be so designed that it can be operated by persons with no radiological protection training. Usually it is required that installation, servicing and periodic testing of the device be performed by a specific licensee, usually the device vendor, whose training and experience with radiation have been evaluated by a regulatory agency. When the user no longer needs the device, it must be transferred to a specific licensee for disposal.
In effect, the user has a " black box" that is to be used according to requirements set out in the regulations and then returned to a specific licensee for safe disposal.
Persons obtaining devices for use under the general license are identified to the NRC ir. cuarterly re,wt:: of tran;fers. The reports are submitted by the specifically licensed distributors. When the general licensee disposes of a device, the regulations require the general licensee to report that fact to the NRC.
The general license for fection 31.5 has been part of the NRC's (or the AEC's) regulations for over 25 years.
Section 10 CFR 31.7 of the NRC's regulations provides a general license for the use of luminous safety devices, containing radioactive material, in aircrcft.
An estimated 60,000 of these devices are used under the Section 31.7 general license. The device may be used to mark exit ways in the event of a power failure.
The devices may cost between forty and two-hundred dollars.
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Devices used under the license inust be manufactured and initially transferred under a specific license issued by the NRC or an Agreement State.
The device must not be easily disassembled and must pass a series of prescribed prototype tests. When the licensee no longer needs the device he must follow established disposal instructions.
Persons obtaining devices for use are identified to the NRC in an annual transfer report. These reports are submitted by the specifically licensed distributor.
TheSection31.7generallicensehasbeenpartoftheNRC's(andtheAEC's) regulations for over 20 years.
Section 10 CFR 31.8 of the NRC's regulations provides a ceneral license for the use of americium-241 in calibration or reference sources. Under this license a person may obtain and use the sources only if they hold a specific license issued pursuant to 10 CFR 30 or equivalent provisions of an Agreement State.
An estinated 200 of these sources are used under the Sectinn 31.8 license.
Devices used under tl.is license must be manufactured and initially transferred under a specific license issued by the NRL or an Agreement State.
The source must be so designed as to withstand the prototype tests prescribed by the regulations. When the user no longer needs the source it must be disposed of by transfer only to a specific licensee.
Persons obtaining the source for use under the license are reported to the NRC under a condition of the manufacture license.
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The general'Iicense Section 31.9 has been part of the NRC's (and the AEC's) regulations for over 20 years.
f Section 10 CFR 40.22 of the NPC's regulations provides a general license for the use of small quantities of source material.
An estimate'of the total licensees under this section cannot be easily made.
There are no reporting requirements and the user is exempt from Parts 19 and
- 20. Therefore the number of general licensees will be obtained during the study by contacting distributors of source material.
l Source material distributed under this general licerse is not required to be manufactured and distributed under a srecific license issued by the NRC or an Agreement State.
i The general license in Section 40.22 has been part of the NRC's regulations for over 24 years.
Section 10 CFR 40.25 of the NRC's regulations provides a general license for
- the use of certain industrial products or devices which contain depleted uranium.
l An estimate of the number of devices used under the general Itcense will be f
obtained during the study.
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Devices used under the general license must be manufactured and distributed under a specific Ilcente issued by the NRC or by an Agreement State. Persons using devices under this Itcense are exempt from 10 CFR Parts 19, 20, and 21.
Persons obtaining devices for use under this general license are identified to j
the NPC by filing of NRC Form 244 l
The general license Section 40.25 has been part of the NRC's (and the AEC's) l l
regulations for over 10 years.
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Section 10 CFR 70.19 of the NRC's regulations provieles a general licerse for the use of plutonium calibration or reference sources. Under this general J
Iicense a person may obtain and use the sources only if they have a specific license issued by NRC pursuant to 10 CFR 30 or equivalent provisions of an Agreement State.
I Devices used under Section 70.19 general license rust be manufactured and initially transferred under a specific license issued by the NRC or an Agreement State. The sources must be designed to withstand the prototype tests l
prescribed by the regulations. When the user no longer needs the source, it i
must be disposed of by transfer to a specific itcensee.
Persons obtaining.the sources for use under the general license are not required by regulations to be reported to the NRC.
ThegenerallicenseSection70.19hasbeenapartoftheNRC's(andtheAEC's) regulations for over ?! years.
AlthoughthegererallicenseslistedabovehavebeenpartoftheNRC's(andthe AEC's)regulationsfornumerousyears,theNRChaslittleinformationabouthow effective this general license has been in protecting the health and safety of workers and the public. The NRC has capended little effort in inspection l
visits to the users of these devices. This is at Icast partially a consequence of the relatively small radiation risk of these productswben compared to the risk of other NRC specific licensed installations. With limited manpower for l
performance of inspections, the NRC has given very little regulatory attention to general licensees.
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Duplication With Other Collection of Information The information collected under this study will be added to infortnation resulting from inspections of general Itcensees by regulatory agencies in Agreement States and by the NRC's Office of Inspection and Enforcement. The number of these inspections to be performed over the next several months is uncertain because of competing, higher priority demands for the inspectors' time. Because of those demands, inspection of more than 11 of the general licensed device users is not expected. However, in selecting genei 1 licensees to contact under the subject study, care will be taken to avoid users that have been inspected recently.
In sore instinces the survey questions will duplicate information on transfers of devices that Itcensees are currently required to submit under the regulations. For example, if the general licensee transferred a device and if the device was not transferred in order to obtain a replacement, then the
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general licersee was required tu report the disposition of that 'tvices.
In this insunce, tho question about transferred devices in item 12 of the survey questionnaire may olicit a response that should already be known to NRC.
However, the duplication as to a small sample of the population is necessary in order to investigate indications that those current requirements may no be effective in maintaining accountability of the radioactive material.
_ Consultations Outside_the NRC Regulatory groups responsible for radiation control in the 28 Agreement States have recoceended (through the Cnnference of Radiation Control Program Directnrs)thatthesubjectstudybeperformed. Those groups are contributing to the study by sharing with NRC the results of inspectiers of their respective general liter. sees. Several vendors of devices have been consulted and they have offered assistarce if NRC difficulty in contacting users of devices under the general licenses, n
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Description of the Information Collection Number and Type of Respondents An estimated 160,000-250,000 devices, other than gauges, are used under the gereral Itcenses listed in the previous section.
It is not possible to obtain an exact number of general licensees. However, we have estimated that there are on the order of 4,000 users under these general licenses. We do not plan to contact more than approximately 10 percent of the users (400) by telephone interviews and not more than 2 percent of the users (80) will be visited. The total number of contacts is tependent on manpower and travel funding.
Reasonableness of the Schedule for Collectino Infornation The information for a user would be collected during a single telephone interview or during a single visit af ter setting up the appointment by telephone.
In some instances, if a former user is uncertain about the disposition that was made of a device, a follow-up call may be made af ter the user has had an opportunity to check its records.
Method of Collecting the Information NRC employees will interview general license users by telephone and by onsite visits. A copy of the survey questionnaire will be coepicted by the interviewer on the basis of the user's answers to short ouestions. An alternative considered was that of a large number of inspections by NRC's Inspection and Enforcement personnel. This alternative was not pursued because of a short supply of inspectors and the need to use available inspectors on higher priority work.
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.c Another alternative considered was that of senritng a questionnaire to the general licensee and asking that it be completed and rentreet. This alternativewasnotselectedbecauseofanticisatedproblemsinaddressingthe
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questionnairetotheappropriateindividualwi.hindhegenerallicensee's organization. By use of the telephone and. ext.la'ining the NRC's interest to the person'at the general licensee's facility, there'may be a greater probability of contacting knowledgeable individuals than would be the case with a letteh;,
1 Estimate of Burden On a one-time basis, the general licensee,that is interviewed by telephone would spend 30 minutes or 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />.
If 400 users were called, this represe7.t13 f
200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> and at $60/hr represents $12,000.
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s Onaone-time-onlybasis,thegenerallicen'seethatisvisitedwouldsiend1 hour.
If 80 general licersees are visited, this represents 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> and
$4,800. The total burden of calls an6 vjs1ts'is estin ted to be 28Ihours.
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j' The total cost of calls and visits is estimated at $16,800. Thes(estimates f'
are based upon consideration of the short questions to be asked and the expected short oral responses.
It is anticipated that, in some instances, the major portion of the time will be spent in locating the individual who is knowledgeable about the dev'ce.
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Estimate of the Cost to the Federal Government This information collection will be on a one-time-only basis.
It is estimated that 5 part-time NRC employees and I permanent NRC employee will be employed for an accumulative time of 8 weeks collecting the information. The surveys will be performed as tire permits over the next 9 months. This represents 1600 person-hours by NRC part-time employees and 320 person-hours by the permanent NRC employee. The estimated employee cost for collecting the information, based on $20/hr for the part-time employees and'$60/hr for the permanent employee, is $51,200. The estimated travel cost is $15,00. The-total cost to the Federal Government for collecting the information is estimated to be $66,200. Subsequently, the information will be ar,slyzed to determine what changes, if any, should be made in the regulatory program for the use of gauges under general license. This analysis is expected to require 2 person-months of effort at a cost of approximately $70,000.
In view of present uncartainty about what changes may be needed, no estimate can be made at this time of the cost of implementing these changes.
Encisoure: Survey Questionnaire.
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SURVEY QUESTIONNAIRE
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For Telephone Survey Use Items 1-12.
For On-Site Visit use Items 1-14.
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.1.
Nameandaddressofgeneral,licenseeNameandtelephonenumberof m
Principal business of the' general licensee, individua'l contacted.
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2.
Purpose for which the device (s) are used (e.g., gas' chromatography, X-Ray flourescence, exit lights', or static eliminators.
N 3.
For escn device, identify the following:
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Manufacturer or initial transferor f')
.b.
Model number c.
Radionuclide in the source d.
Quantity of radioactivity in the source and date of determination of the quantity.
e.
Date the de/ ice was received.
f.
Date of source replacement, if any.
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4.
Name of individual company who installed the device.
5.
Does the device have a durable, legible, clearly visible label?
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6.
Does the general licensee have a copy of the general license?
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Does the:gentiral licensee have a copy of the initial ridiation survey performed at the time of installation?
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8.
Leak Tests (if applicable)
M, a.
Have the tests ~been performed?
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- b. - Narre of firm or person who performed the test.
c.
Does the general licensee have < records of leak test results?
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.ON-OFF MECHANISM AND INDICATOP TESTS (if applicable) a.
Have the tests been performed?
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Name of firm or person who performed the test c.
Does the general licensee have records of on-off mechanism and indicator test?
- 10. Has the device been moved from its original location? It so, by whom?
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- 11. Does the general licensee have personnel who are aware of the general license conditions and responsible for assuring compliance with the general license conditions?
- 12. Has the general licensee made any transfer of gauges? If so, were the gauges transferred to specific licensees?
- 13. Your observations of the program conducted by the general licensee. For example, are gauges in a dirty environment so that labels become obscured?
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Have gauges been removed from use and stored in uncontrolled areas, etc.?
- 14. Any observations regarding environment of use as it relates to stress J
imposed on safety aspects of the gauge.
(e.g., use of a gauge on a glass melting furnace where the gauge may be subjected to high temperatures).
Note:
In some instances one or more of the above items will not be applicable, e.g., Item 8 would not apply to devices containing krypton-85 or tritium and Item 9 would not apply to devices containing tritium.
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