ML20128M354
| ML20128M354 | |
| Person / Time | |
|---|---|
| Issue date: | 05/20/1985 |
| From: | Norry P NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | |
| References | |
| OMB-3150-0124, OMB-3150-124, NUDOCS 8505310644 | |
| Download: ML20128M354 (13) | |
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DESIGRATED ORIGTH!1 standard Fc.m N ~
(Re3 Serember 1983)
R8QU8St for 0MB Ruiem =f - (4 a frnportant R:ad instructior s before comp:eting form. Do not use the same SF 83 Send three copies of this form, the material to be reviewed, and fc paperwork-three copies of the supporting statement. to:
t; request both an Executse Order 12291 review and approval under the Paperwork Reduction Act.
Answer all questions in Part 1. If this request is for review under E.O. Office of Information and Regulatory Affairs 12291. complete Part 11 and sign the regulatory certification. !! this Office of Management and Budget requist is for approva! under the Paperwork Reduction Act and 5 CFR Attention: Docket Library. Room 3201 1320. skip Part II. comp;ete Part ll1 and sign the paperwork certification. Washington. DC 20503 PART l.-Complete This Part for All Requests.
I~ Department / agency and Esteaufofface onginating request 2 Agency code U.S. Nuclear Regulatory Conraission 3 1 5 3
- 3. Name of person who can best answer questions regarding this request Telephone number Steven L. aaggett (301 M27-9005 __
- 4. Title of infortnation collection or rulemaking Survey of Users of Devices Under General License
- 5. Legat authority for information collection or rule (cite United States coce. Pubhc Law, or Emecutne Orcer) 4? UsC ??ril(n) . or
- 6. Affected public (check att fhatapply) 5 rederaiagencies or employees 3 0 rarms s O Non-profitinstitutions 1 O individuaisorhousehoids 2 O state oriocaigovernments 4 O Businesses or einer for. profit 7 0 smaribusinessesororganizations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291 _-
- 7. Regulation Identifier Number (RIN)
_ _ _ _. or. None assigned
- 8. Type of submission (check one un each category)
- Type of review requested Classification Stage of development 1 standard 1 O uajor 1 proposed or draft 2 O pending 2 O Nonmajor 2 rinat or ir.teren tinai. witn pnor proposai 3 0 Emergency 3 0 rinai or intenm finai. without prior proposai 4 0 statutoryorjudiciaieeadiine c
- 9. CF.4 section affected CFR . - _
- 10. Does this regu!ation contain reporting or recordkeeping requirements that require OMB approvat under the Paperwork Reduction Act and 5 CrR 1320? .. . . . . . . . . . . . O Yes D ua
- 11. If a rnajor ruie. is there a regulatory impact anaiysis attached? . . . . . . . . . . . .. 1 Yes 2 O Na if"No ** did OMB waive the analysis? .. . . ... . .
3 O ves 4 QNe C: rtification for Regulatory submissions In submatting this request for CMB review the authorized regulatory centact and the program of f;cial certify that the requirements of E.o.12291 and any applicat ir policy directives have been complied with, ~~
Date signature of program official I
s n_ture of author zed regulatory contact Date f
8505310644 ORg B5052 EUS
Pe r ows
- 83 108 P es e.ti. .1 r . *f hsN 75.eet.ces 0oo 634- 034 ebso.ete 5 CFR 13;O am: f O .1. ..
' g;g 1 55' SUPPORTING STATEMENT FOR SURVEY OF USERS OF DEVICES UNDER GENERAL LICENSES IN 10 CFR 31.5, 31.5, 31.7, 31.8 40.22, 40.25, AND 70.19 Summary of Study 4
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 150,000-250,000 devices are used under these general licenses. Traditionally, NRC (formerly AEC) has little contact with generally licensed gauge users. In the study, summer employees of NRC will ask device users to account for devices that they have received and to answer short questions about installation and
- maintenance of the devices. No written responses will be required of device users. The survey questionnaire (sample attached) 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.
-Justifications
- Need for and Practical Utility of Information Collected Under a special study initiated during the summer of 1984, the NRC contacted a sampling of persons that use gauges containing byproduct material. These persons were licensed under the Section 31.5 general license. The contacts were made under OMB approval number 3150-0124. This study was to acquire data and answer the questions of whether NRC has a problem with respect to guages users under the general license.
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PART lli.-C:rnpl;ts This P rt Onlyif th2 R;qu;st is far Appr: val:Io Citi;ctirn r f Inf ~ rrn^ti n Und:r th ? P7perw'rk R;ducti~n Act rnd 5 CFR 1320.
- 13. Abstract-Describe needs. uses and affected publ>c in 50 words or less Devices containin,j radioactive Lyproduct material are useJ in a nuat.er of industrial applications, under a general license established Ly the Comission, for producing light, analytical measurements, or elimination of static. MRC will conduct a survey of a sample of users to acquire data for a study of the effectiveness of the general license in protecting PM ic T @ t' and r3fety.
- 10. Type of information collection (check only one) laformation collections not containedin rules 1 @ Regular submission 2 O trnergency submission (certificationattached)
I; formation collections contained in rules s rinai or interim finai witnout prior NeRu 7. cnier cate of e,pected o, actuai reeerai 3 O taisting regutation (no chanse proposed)
A O Reguiar submission Reg ster puer cation at this stage of ruiemnoni 0 Notice of proposed rulemaking(NPRM) l B O Emergency submission (certification attached > (monta dar. rear >:
5 0 rinai. NPRu was prev;ouiry pubiisned I
- 15. Type of review requested (check only one) 4 O Reinstatement of a previousfy approved collection for which approsal 1 O New collection he5 Pi "d 2O Revisionof acurrentryapprovedcorrection 5 Existing collection in use without an oMB controi number 3 O tatension of the expiration date of a currently approved collection without any change in the substance or in the method of coffection
- 22. Purpose of information collection (check as many as apply)
- 16. Agency report form number (s)(include standard /optnanalform number (s)) -
1 Application for benefits N/A 2 Program evaluation
- 17. Annuai reporting or disclosure burden 3 General purpose statistics 1 Number of respondents . . .
430 4 Q Regutatory or compnance 2 Number of responses per respondent .....
I 5 @ Program planning or management 3 Total annual responses (line 1 times line 2) .
430 s Research 4 Hours per response . . ... .. .
0.53 7 O Audit 5 Total hours (Lne 3 times line 4) 280 _
- 23. F eequency of recordheeping or reporting (check allthar apply)
- 18. Annuairecordkeepingburden 1 O Accordkeeping I umber of recordkeepers ....
Reportins 2 Annual hours per recordkeeper. .... . .
3 Total recordkeeping hours (hne 1 times line 2) . 2 O onoccasion 4 Recordkeeping retention period .
years 3 Weekly ,
- 19. Total annual burden 4 O uontner 1 Requested (lone 17-5 plus line 18-3) .
200 $ Quarterly O s O semi-annuariy 2 in current oMa inventory . .. .
3 Difference (line lless tne 2/ . ...
+ 280 7 Annuarty 8 0 B,ennially Esplanation aldifference 4 Program change . ......... + 230 9E other (describe): _Ones-t % surver _
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_ 5 Adjustmert 24. Respondents
- cb! gation to comply (check the strongest celegation (Aat a/sgo.c
- 20. Current (most recent) oMB control number or comment number 3150-0124 1 voiuntary
- 21. Reg ested espiration date
- 2 Required to obtain or retain a benefit 3 0 uandatory 12/31/05
- 25. Are the respondents primarity educational agencies or institutions or is the primary purpose of the collection related to F
- 26. Does the agency use sampling to setect respondents or does the agency recommend or prescribe the use of sampling or statist; cal analyses . .
by respondents? . .,,. . . .. . . . . .. . . . .
.hYesC-
- 27. Regulatory authority for the information collection FR ; or.other (specify):
CFR : or o
P.p.rwork Certif. cation in submitting this recuest for oMB approval, the agenc'y head. the senior offecial or an authorized representative cert.fies thl Prra cy Act. statistical standards or directrves, and any ether applicable information pohcy d'<ectives have been compi.ed with.
$ gniture of program official
- i Cate s gnature of agency heac. the sen.or o't.c.ai or an aenor :eo representative ,
jf , Patricia G. !!orry, Director g g ._ p4 .
' d /i/ Office of AJninistration s
. 2 from this study we found that in fact the general licensees were not, in all l ' cases, adhering to the rules and regulations of Section 31.5. Furthermore, some gauges were found to be unaccounted for and a final disposition could 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 .
i ' licenses in 10 CFR. These other users possess.between 150,000-250,000 devices I (other than gauges) under the general licensef}f 10 CFR 31.3, 31.5, 31.7 31.8,
, 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.
' These conta' cts will be made by NRC summer employees. The summer employ ~ees will not be authorized to perform NRC inspections but will merely gather information.
[ We expect to have acquired the major portion of the data by October 1985. At that time we will develop tentative findings to help answer the questions of whether NRC also has a problem with the other general
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licenses and if there is a problem, what remedial action should be .taken.
The results of this survey will be used with results of the Summer 1984 study to support any corrective a'ction that may be deemed necessary.
F - The following section provides a b'rief 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. That is, the person does not submit an application for a license authorizing use of the radioactive material.
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. .
t 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 dol.lars. -
Devices used under the Section 31.3 general license must be . manufactured and distributed under a specific license issued only by the NRC.
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- 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
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markers, analytica1 equipment) is used under the license. The devices may be 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.
Devices used under the general license in S 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.
l Persons obtaining devices for use under the general license are identified.to the NRC in quarterly reports of transfers. 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 S 31.5 has been part of the NRC's (or the AEC's) regula-tions for over 25 years. -
I Section 10 CFR 31.7 of the NRC's regulations provides a general license for the l use of luminous safety devices, containing radioactive material, in aircraft.
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An estimated 60,000 of these devices are used under the S 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.
Devices used under the license must be manufactured and initially transferred under a specific license issued by the NRC or an Agreement State. The device must not be easily disasse,abled 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.
The Section 31.7 general license has been part of the NRCs (and the AECs) regulations for over 20 years.
Section 10 CFR 31.8 of the NRC's regulations provides a general 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 estimated 2,00 of these sources are used under the Section 31.8 license.
Devices used under this license must be manufactured and initially transferred under a specific license issued by the NRC 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 license S 31.9 has been part of the NRC's (and the AEC's) regulations for over 20 years.
Section 10 CFR 40.22 of the NRC'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.
Source material distributed under this general license is not required to be manufactured and distributed under a specific license issued by the NRC or an agreement state.
The general license in S 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 produci.s or devices which contain depleted uranium.
An estimate of the number of devices used under the general license will be obtained during the study.
l l Devices used under the general license must be manufactured and distributed under a specific license
- issued by the NRC or by an agreement state. Persons using devices under this license are exempt from 10 CFR Parts 19, 20, and 21.
Persons obtaining devices for use under this general license are identified to the NRC by filing of NRC Form 244 -
The general license S 40.25 has been part of theyRC's (and the AEC's) regulations for over 10 years.
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, Section 10 CFR 70.19 of the NRC's regulations provides a general license for the use of plutonium calibration of reference sources. Under this general
?'~ ~ 1icense 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.
Devices used under S 70.19 general license must 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 prescribed by the regulations. When the user no longer needs the source, it must be disposed 4
of by transfer to a specific licensee.
- Persons obtaining the sources for use under the general license are not' required ,
-by-regulations to be reported to the NRC.
The general license S 70.19 has'been a part of the NRC's (and the AECs) regula-I tions for over 21 years.
i Although the general licenses listed above have been part of the NRC's (and the AEC's) regulations for numerous years, the NRC has little information about how .
effective this general license has'been in prot'ecting the health and safety of workers and the public. The NRC has expended little effort in inspection visits to the user's of these devices. This is at least partially a consequence
.of the relatively small radiation risk of a' device installation compared to the -
risk of other NRC licensed installations. With limited manpower for per-
-formance of inspectio'ns, the NRC has given very little regulatory attention to device users.
Duplication With'Other Collection of Information The information collected under this study will be added to information resulting
-from inspections of general licensees 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 few mor ths is uncertain because
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of; competing, higher priority demands for the inspectors' time. Because of those demands, inspection of more than 1% of the general licensed device users y
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is not expected. However, in selecting general licensees to contact under the subject study, care will be taken to avoid users that have been inspected recently.
In some instances the survey questions will duplicate information on transfers of devices that licensees are currently required to submit under the regulations.
For eiample, if the general licensee transferred a device and if the device was not transferred in order to obtain a replacement, then the general licensee was required to report the disposition of that devices. In this instance, the question about transferred devices in item 12 of the survey questionnaire may i
elicit a response that should already be known to NR'C. However, this du'pli-cation as to a small sample of the population is necessary in order to investi-gateindicationsthatthosecurrentrequirementsmaynotbeeffectivein maintaining accountability of the radioactive material.
Consultations Outside the NRC I
Regulatory groups responsible for radiation control in the 27 Agreement States have recommended (through the Conference of Radiation Control Program Directors) that the subject study be performed. Those groups are contributing to the study by sharing with NRC the results of inspections of their respective
, general licensees. Several vendors of devices have been consulted and they have I
offered assistance if NRC has difficulty in contacting users of devices under
' --. the general licenses.
Description of the Information Collection I- Number and Type of Respondents An estimated 160,000-250,00 devices, other than gauges, are used under the general licenses listed in the previous section. It is not possible to obtain an exact I number of general licensees. However, we have estimated that there are on the l
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 i
and not more than 2 percent of the users (80) will be visited. The total number of contacts is dependent on manpower and travel funding.
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Reasonableness of the Schedule for Collecting Information The information for a user would be collected during a single telephone inter-view or during a single visit after setting up the appointment by telephone.
In some instances, if a former user is uncertain about the disposi-tion that was made of a device,.a follow-up call may be made after the user has had an opportunity to check its records.
Method of CoMect.ino the Information NRC summer employees yill interview gauge users by telephone and by onsite i
visits. AcopyofthesuIveyquestionnairewillbecompletedbytheinterviewer onthebasisoftheuser'sanswerstoshgrtquestions. 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.
Another alternative considered was that of sending a questionnaire to the general licensee and asking that it be completed and returned. This alternative was not selected because of anticipated problems in addressing the questionnaire to the appropriate individual _ within the general licensee's organization. By use of the telephone and explaining 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 letter.
Estimate of Burden On a one-time-only 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 represents 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.
On a one-time-only basis, the general licensee that is visited would spend 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. If 80 general ricensees are fisit'ed, thiis fepresent's 8'O hours and
$4,800. The total burden of calls and visits is estimated to be 280 hours0.00324 days <br />0.0778 hours <br />4.62963e-4 weeks <br />1.0654e-4 months <br />.
The total cost of calls and visits is estimated at $16,800. These estimates are based upon consideration of the short questions to be asked and the expected short oral responses. It is anticipated that, in some instances, 8
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.o the major portion of the time will be spent in locating the individual who is knowledgeable about the device.
Estimate of the Cost to the Federal Government This information collection will be on a one-time-only basis. It is estimated that 5 NRC Summer Employees and 1 permanent NRC employee will be employed full time for 8 weeks collecting the information. This represents 1600 person-hours by NRC Summer Employees and 320 person-hours by the permanent NRC employee.
The estimated employee cost for collecting the information, based on $20/hr for the Summer Employees and $60/hr for the permanent employee, is $51,200. The estimated travel cost is $15,000. The total cost to the Federal Government for collecting the information is estimated to be $66,200. Subsequently, the information will be analyzed 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 approxi-mately $20,000. In view of present uncertainty about what changes may be needed, no estimate can be made at this time of the cost of implementing these changes.
Enclosure:
Survey Questionnaire.
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c-SURVEY QUESTIONNAIRE For Telephone Survey use Items 1 - 12.
For On-Site Visit use Items 1 - 14.
- 1. Name and address of general licensee.
Name and telephone number of individual contacted.
Principal business of the general licensee.
- 2. Purpose for which the device (s) are used (e.g., gas chronodegraphy, X-Ray flourescence, exit lights, or static eliminators.
- 3. For each device, identify the following:
- a. Manufacturer or initia' transferor
- 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 device was received.
- f. Date of source replacement, if any.
- 4. Name of individual company who installed the device.
- 5. Does the device have a durable, legible, clearly visible label?
- 6. Does the general licensee have a copy of the general license? .
- 7. Does the general licensee have a copy of the initial radiation survey performed at the time of installation?
- 8. Leak tests
- a. have the tests been performed?
,, b. 'Name of firm or person who performed the test
- c. Does the general licensee have records of leak test results?
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I .s K 9. On-off mechanism and indicatar tests
- a. Have the tests been performed?
- b. Name of firm or person who performed the test
- c. Does the general licensee have records of on-off mechanism and indicator tests?
- 10. Has the device been moved from its original location? If so, by whom?
- 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 transfers 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?
Have gauges been removed from use and stored in uncontrolled areas, etc.?
-14. Any observations regard'ng i environment of use as it relates to stress imposed on safety aspectjs of the gauge. (e.g., use of a gauge on a glass melting furnace where t1e gauge may be subjected to high temperatures).
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l Note: In some instances one or more of tiie above items will not be applicable,'e.g., item 8 would not apply to gauges containing krypton-85 or tritium and item 9 would not apply to gauges containing tritium. -
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